Actinic KeratosisPhase 2NCT01475955
Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
A Phase 2 study testing Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation and broad area ALA 3-hour incubation in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation and broad area ALA 3-hour incubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 235 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 6-20 Grade 1/2 AKs on the face or scalp
- a history of AK therapy within the treatment area at least twice in the two years prior to study entry
Who cannot join
- Pregnancy
- Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- plans to be exposed to artificial tanning devices or excessive sunlight during the trial
- Subject is immunosuppressed
- unsuccessful outcome from previous ALA-PDT therapy
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- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- any condition which would make it unsafe for the subject to participate in this research study
- currently enrolled in an investigational drug or device study
- has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
- known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
- Subject has;
- an active herpes simplex infection OR
- a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
- use of the following topical preparations on the extremities to be treated:
- Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
- Cryotherapy within 2 weeks of initiation of treatment
- Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- Two or more ALA PDT treatments in the past 6 months
- use of systemic retinoid therapy within 6 months of initiation of treatment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
DermResearch, Inc.
Austin, Texas, 78759
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, 45220
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056
UCSD Dermatology Perlman Ambulatory Clinic
La Jolla, California, 92037
Dermatology Research Associates
Los Angeles, California, 90045
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Virginia Clinical Research Inc
Norfolk, Virginia, 23507
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Medical Research Center, PC
Portland, Oregon, 97223
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
- Conditions
- Actinic Keratosis
- Being tested
- Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation, broad area ALA 3-hour incubation, Spot ALA 2 hour incubation, Vehicle PDT
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Area ALA 1-hour incubationDrug
Also called Levulan
20% ALA, broad area, 1 hour incubation
Broad Area ALA 2 hour incubationDrug
Also called Levulan
20% ALA broad area 2-hour incubation
broad area ALA 3-hour incubationDrug
Also called Levulan
20% ALA broad area 3 hour incubation
Spot ALA 2 hour incubationDrug
Also called Levulan
20% ALA spot 2 hour incubation
Vehicle PDTDrug
Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Blue Light TreatmentDevice
Also called BLU-U
10 J/cm2 blue light delivered at 10 mW/cm2
| Study group | Role | What they receive |
|---|---|---|
| Broad Area ALA 1-hour incubation | Experimental | Broad Area ALA 1-hour incubation Receives: Drug: Broad Area ALA 1-hour incubation; Device: Blue Light Treatment |
| Broad Area ALA 2-hour incubation | Experimental | Broad Area ALA 2-hour incubation Receives: Drug: Broad Area ALA 2 hour incubation; Device: Blue Light Treatment |
| Broad Area ALA 3-hour incubation | Experimental | Broad Area ALA 3-hour incubation Receives: Drug: broad area ALA 3-hour incubation; Device: Blue Light Treatment |
| Spot ALA 2-hour incubation | Experimental | Spot ALA 2-hour incubation Receives: Drug: Spot ALA 2 hour incubation; Device: Blue Light Treatment |
| Vehicle PDT | Placebo comparator | VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group. Receives: Drug: Vehicle PDT; Device: Blue Light Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance Rate
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 12
Secondary outcomes (69)
Complete Clearance Rate
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 4
Complete Clearance Rate
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 8
Complete Clearance Rate
the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 24
Partial Clearance Rate
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Measured: Baseline, Week 4
Partial Clearance Rate
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Measured: Baseline, Week 8
Partial Clearance Rate
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Measured: Baseline, Week 12
Partial Clearance Rate
proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
Measured: Baseline Week 24
AK Clearance Rate
AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]
Measured: Baseline, Week 4
AK Clearance Rate
AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]
Measured: Baseline, Week 8
AK Clearance Rate
AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]
Measured: Baseline, Week 12
AK Clearance Rate
AK Clearance Rate (AKCR) for a subject is defined as:
100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]
Measured: Baseline, Week 24
Subject Satisfaction Score
0 = no improvement or worsening (not satisfied at all)
- = slight improvement (slightly satisfied)
- = moderate improvement (moderately satisfied)
- = excellent improvement (very satisfied)
Measured: Week 24
Hyperpigmentation at Baseline
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Baseline
Hyperpigmentation at Visit 2
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: 24-48 Hours after PDT #1
Hyperpigmentation at Visit 3
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Week 2
Hyperpigmentation at Visit 4
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Week 4
Hyperpigmentation at Visit 5
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Week 8
Hyperpigmentation at Visit 6
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Week 12
Hyperpigmentation at Visit 7
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Week 24
Hypopigmentation at Baseline
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Baseline
Hypopigmentation at Visit 2
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: 24-48 Hours after PDT #1
Hypopigmentation at Visit 3
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Week 2
Hypopigmentation at Visit 4
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Week 4
Hypopigmentation at Visit 5
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Week 8
Hypopigmentation at Visit 6
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Week 12
Hypopigmentation at Visit 7
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Week 24
Erythema at Baseline
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Baseline
Erythema Post-Light Treatment
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: 5 minutes after PDT #1
Erythema at Visit 2
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: 24-48 hours after PDT #1
Erythema at Visit 3
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 2
Erythema at Visit 4
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 4
Erythema at Visit 5 (Pre-drug)
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 8 pre-drug
Erythema at Visit 5 (Post-light)
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 8 5 minutes post light treatment
Erythema at Visit 6
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 12
Erythema at Visit 7
Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Week 24
Edema at Baseline
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Baseline
Edema Post-Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 5 minutes after PDT #1
Edema at Visit 2
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 24-48 hours post PDT#1
Edema at Visit 3
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Week 2
Edema at Visit 4
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Week 4
Edema at Visit 5 (Pre-drug)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Week 8 pre-drug
Edema Post PDT #2
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 5 minutes post PDT #2
Edema at Week 12
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Week 12
Edema at Week 24
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Week 24
Stinging/Burning at Baseline
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Baseline
Stinging/Burning During Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: During PDT #1 (most intense sensation)
Stinging/Burning Post Light-Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: 5 minutes post PDT #1
Stinging/Burning at Visit 2
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: 24-48 hours post PDT #1
Stinging/Burning at Visit 3
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Week 2
Stinging/Burning at Visit 4
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Week 4
Stinging/Burning at Visit 5 (Pre-drug)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Week 8 prior to drug
Stinging/Burning at Visit 5 During PDT#2
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: during PDT #2
Stinging/Burning at Visit 5 Post PDT#2
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: 5 minutes post PDT #2
Stinging/Burning at Visit 6
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Week 12
Stinging/Burning at Visit 7
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.
Measured: Week 24
Scaling and Dryness at Baseline
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Baseline
Scaling and Dryness at Visit 2
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: 24-48 hours after PDT #1
Scaling and Dryness at Visit 3
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Week 2
Scaling and Dryness at Visit 4
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Week 4
Scaling and Dryness at Visit 5
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Week 8
Scaling and Dryness at Visit 6
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Week 12
Scaling and Dryness at Visit 7
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Week 24
Oozing/Vesiculation/Crusting at Baseline
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Baseline
Oozing/Vesiculation/Crusting at Visit 2
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: 24-48 hours after PDT #1
Oozing/Vesiculation/Crusting at Visit 3
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Week 2
Oozing/Vesiculation/Crusting at Visit 4
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Week 4
Oozing/Vesiculation/Crusting at Visit 5
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Week 8
Oozing/Vesiculation/Crusting at Visit 6
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Week 12
Oozing/Vesiculation/Crusting at Visit 7
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Marcus, MD, PhD, Study director, DUSA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475955
- Sponsor's protocol ID
- CP0105
- Status last verified
- Sep 2016
- First submitted
- 15 Nov 2011
- Last updated
- 28 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Piacquadio D, Berman B, Siegel DM, Bhatia N, Brocato J, Squittieri N, Pariser DM. Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities. J Clin Aesthet Dermatol. 2023 Dec;16(12):46-51.
PubMed 38125671
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp
- ClinicalTrials.gov ID
- NCT01475955
- Acronym / sponsor ID
- CP0105
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 24 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Broad Area ALA 1-hour incubation | Experimental | Drug: Broad Area ALA 1-hour incubation, Device: Blue Light TreatmentBroad Area ALA 1-hour incubation |
| Broad Area ALA 2-hour incubation | Experimental | Drug: Broad Area ALA 2 hour incubation, Device: Blue Light TreatmentBroad Area ALA 2-hour incubation |
| Broad Area ALA 3-hour incubation | Experimental | Drug: broad area ALA 3-hour incubation, Device: Blue Light TreatmentBroad Area ALA 3-hour incubation |
| Spot ALA 2-hour incubation | Experimental | Drug: Spot ALA 2 hour incubation, Device: Blue Light TreatmentSpot ALA 2-hour incubation |
| Vehicle PDT | Placebo comparator | Drug: Vehicle PDT, Device: Blue Light TreatmentVEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 6-20 Grade 1/2 AKs on the face or scalp
- a history of AK therapy within the treatment area at least twice in the two years prior to study entry
Key exclusion criteria (23 listed)
- Pregnancy
- Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- plans to be exposed to artificial tanning devices or excessive sunlight during the trial
- Subject is immunosuppressed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad Area ALA 1-hour incubationAlso: Levulan20% ALA, broad area, 1 hour incubation | Drug | Broad Area ALA 1-hour incubation |
| Broad Area ALA 2 hour incubationAlso: Levulan20% ALA broad area 2-hour incubation | Drug | Broad Area ALA 2-hour incubation |
| broad area ALA 3-hour incubationAlso: Levulan20% ALA broad area 3 hour incubation | Drug | Broad Area ALA 3-hour incubation |
| Spot ALA 2 hour incubationAlso: Levulan20% ALA spot 2 hour incubation | Drug | Spot ALA 2-hour incubation |
| Vehicle PDTLevulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group. | Drug | Vehicle PDT |
| Blue Light TreatmentAlso: BLU-U10 J/cm2 blue light delivered at 10 mW/cm2 | Device | Broad Area ALA 1-hour incubation, Broad Area ALA 2-hour incubation, Broad Area ALA 3-hour incubation, Spot ALA 2-hour incubation, Vehicle PDT |
Primary outcome
Complete Clearance Rate
Time frame: Week 12
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
69 secondary outcomes
Complete Clearance Rate
Time frame: Week 4
Complete Clearance Rate
Time frame: Week 8
Complete Clearance Rate
Time frame: Week 24
Partial Clearance Rate
Time frame: Baseline, Week 4
Partial Clearance Rate
Time frame: Baseline, Week 8
Partial Clearance Rate
Time frame: Baseline, Week 12
Partial Clearance Rate
Time frame: Baseline Week 24
AK Clearance Rate
Time frame: Baseline, Week 4
AK Clearance Rate
Time frame: Baseline, Week 8
AK Clearance Rate
Time frame: Baseline, Week 12
AK Clearance Rate
Time frame: Baseline, Week 24
Subject Satisfaction Score
Time frame: Week 24
Hyperpigmentation at Baseline
Time frame: Baseline
Hyperpigmentation at Visit 2
Time frame: 24-48 Hours after PDT #1
Hyperpigmentation at Visit 3
Time frame: Week 2
Hyperpigmentation at Visit 4
Time frame: Week 4
Hyperpigmentation at Visit 5
Time frame: Week 8
Hyperpigmentation at Visit 6
Time frame: Week 12
Hyperpigmentation at Visit 7
Time frame: Week 24
Hypopigmentation at Baseline
Time frame: Baseline
Hypopigmentation at Visit 2
Time frame: 24-48 Hours after PDT #1
Hypopigmentation at Visit 3
Time frame: Week 2
Hypopigmentation at Visit 4
Time frame: Week 4
Hypopigmentation at Visit 5
Time frame: Week 8
Hypopigmentation at Visit 6
Time frame: Week 12
Hypopigmentation at Visit 7
Time frame: Week 24
Erythema at Baseline
Time frame: Baseline
Erythema Post-Light Treatment
Time frame: 5 minutes after PDT #1
Erythema at Visit 2
Time frame: 24-48 hours after PDT #1
Erythema at Visit 3
Time frame: Week 2
Erythema at Visit 4
Time frame: Week 4
Erythema at Visit 5 (Pre-drug)
Time frame: Week 8 pre-drug
Erythema at Visit 5 (Post-light)
Time frame: Week 8 5 minutes post light treatment
Erythema at Visit 6
Time frame: Week 12
Erythema at Visit 7
Time frame: Week 24
Edema at Baseline
Time frame: Baseline
Edema Post-Light Treatment
Time frame: 5 minutes after PDT #1
Edema at Visit 2
Time frame: 24-48 hours post PDT#1
Edema at Visit 3
Time frame: Week 2
Edema at Visit 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38125671Piacquadio D, Berman B, Siegel DM, Bhatia N, Brocato J, Squittieri N, Pariser DM. Treatment Satisfaction and Acceptability of 20% Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses of the Face, Scalp, and Upper Extremities. J Clin Aesthet Dermatol. 2023 Dec;16(12):46-51.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Marcus, MD, PhD study director
DUSA Pharmaceuticals, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Broad Area ALA 1-hour incubation, Broad Area ALA 2 hour incubation and broad area ALA 3-hour incubation in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Clearance Rate (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01475955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.