Actinic KeratosisPhase 3NCT02137785
Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
A Phase 3 study testing Aminolevulinic Acid (ALA) and Blue Light Photodynamic Therapy Illuminator (BLU-U) 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 keratoses on the upper arms and hands 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?
- Aminolevulinic Acid (ALA) and Blue Light Photodynamic Therapy Illuminator (BLU-U)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2014to Mar 2015
- Phase
- Phase 3
- 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
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity
Who cannot join
- Pregnancy
- grade 3 and/or atypical >1cm AKs within Treatment Area
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
- Subject is immunosuppressed
Show all 16Show fewer
- unsuccessful outcome from previous ALA-PDT therapy
- 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)
- use of the following topical preparations on the extremity 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, within 4 weeks of initiation of treatment.
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
- 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
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
MOORE Clinical Research, Inc
Brandon, Florida, 33609
Shideler Clinical Research Center
Carmel, Indiana, 46032
J&S Studies, Inc
College Station, Texas, 77845
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Dermatology and Research Center
Portland, Oregon, 97210
UCSD Dermatology
San Diego, California, 92122
Spencer Clinical Services
St. Petersburg, Florida, 33716
About this study
Official title: A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands
- Conditions
- Actinic Keratosis
- Being tested
- Aminolevulinic Acid (ALA), Topical Solution Vehicle, Blue Light Photodynamic Therapy Illuminator (BLU-U)
- Keywords
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic Acid (ALA)Drug
Also called Levulan Kerastick
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Topical Solution VehicleDrug
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
Blue Light Photodynamic Therapy Illuminator (BLU-U)Device
10 J/cm2 blue light delivered at 10mW/cm2
| Study group | Role | What they receive |
|---|---|---|
| ALA | Experimental | Not described Receives: Drug: Aminolevulinic Acid (ALA); Device: Blue Light Photodynamic Therapy Illuminator (BLU-U) |
| Vehicle | Placebo comparator | Not described Receives: Drug: Topical Solution Vehicle; Device: Blue Light Photodynamic Therapy Illuminator (BLU-U) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 12
Secondary outcomes (4)
AK Clearance Rate
{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100
Measured: Baseline and Week 12
AK Clearance Rate
{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100
Measured: Baseline and Week 8
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Measured: Week 8
Subject Satisfaction Score
Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 269 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
- NCT02137785
- Sponsor's protocol ID
- CP0108
- Status last verified
- Aug 2015
- First submitted
- 7 May 2014
- Last updated
- 16 Sep 2015
- 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 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities
- ClinicalTrials.gov ID
- NCT02137785
- Acronym / sponsor ID
- CP0108
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 16 Sep 2015
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 keratoses on the upper arms and hands
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALA | Experimental | Drug: Aminolevulinic Acid (ALA), Device: Blue Light Photodynamic Therapy Illuminator (BLU-U) |
| Vehicle | Placebo comparator | Drug: Topical Solution Vehicle, Device: Blue Light Photodynamic Therapy Illuminator (BLU-U) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity
Key exclusion criteria (16 listed)
- Pregnancy
- grade 3 and/or atypical >1cm AKs within Treatment Area
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
- skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
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 |
|---|---|---|
| Aminolevulinic Acid (ALA)Also: Levulan Kerastick20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light | Drug | ALA |
| Topical Solution VehicleLevulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light | Drug | Vehicle |
| Blue Light Photodynamic Therapy Illuminator (BLU-U)10 J/cm2 blue light delivered at 10mW/cm2 | Device | ALA, Vehicle |
Primary outcome
Complete Clearance Rate
Time frame: Week 12
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
4 secondary outcomes
AK Clearance Rate
Time frame: Baseline and Week 12
AK Clearance Rate
Time frame: Baseline and Week 8
Complete Clearance Rate
Time frame: Week 8
Subject Satisfaction Score
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- 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 3 study testing Aminolevulinic Acid (ALA) and Blue Light Photodynamic Therapy Illuminator (BLU-U) 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 1 inclusion and 16 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 16 Sep 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Sep 2015). 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 NCT02137785, 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 16 Sep 2015.