Actinic KeratosisPhase 2NCT02239679
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
A Phase 2 study testing Aminolevulinic Acid, BLU-U and Cryotherapy in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 8 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 (AK) on the face, following treatment with liquid nitrogen cryotherapy. 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, BLU-U and Cryotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2014to Sep 2016
- 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
- Four to fifteen AKs on the face
- histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
- at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
Who cannot join
- Pregnancy
- 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
- unsuccessful outcome from previous ALA-PDT therapy
Show all 15Show fewer
- 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)
- has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
- 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
- Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
- Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
- use of systemic retinoid therapy within 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Shideler Clinical Research Center
Carmel, Indiana, 46032
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Sadick Research Group
New York, New York, 10075
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
UCSD Dermatology
San Diego, California, 92122
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
The purpose of this study is to determine if Levulan photodynamic therapy (PDT) is safe and effective in the treatment of actinic keratoses (AK) on the face, following treatment with liquid nitrogen cryotherapy.
- Conditions
- Actinic Keratosis
- Being tested
- Aminolevulinic Acid, Topical Solution Vehicle, BLU-U, Cryotherapy
- 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 AcidDrug
Also called Levulan Kerastick, ALA
20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Topical Solution VehicleDrug
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
BLU-UDevice
Also called BLU-U Blue Light Photodynamic Therapy Illuminator
10 J/cm2 blue light delivered at 10 mW/cm2
CryotherapyProcedure or surgery
Also called Liquid Nitrogen
Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
| Study group | Role | What they receive |
|---|---|---|
| ALA X3 | Experimental | Cryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments Receives: Drug: Aminolevulinic Acid; Device: BLU-U; Procedure: Cryotherapy |
| VEH | Placebo comparator | Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. Receives: Drug: Topical Solution Vehicle; Device: BLU-U; Procedure: Cryotherapy |
| ALA X2 | Experimental | Cryotherapy followed by 2 aminolevulinic acid + BLU-U treatments Receives: Drug: Aminolevulinic Acid; Device: BLU-U; Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of AKs in Treatment Area
Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
Measured: Week 52
Secondary outcomes (8)
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Measured: Week 4
Subject Satisfaction Score
Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all) Unknown
Measured: Week 52
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Measured: Week 12
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Measured: Week 24
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Measured: Week 36
Proportion of Subjects With 0 AKs
Normalized based on number of lesions present at Baseline
Measured: Week 52
Recurrence Rate
Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
Measured: Week 52
Duration of Response
Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first
Measured: within 52 weeks after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionSep 2016
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
- 166 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
- NCT02239679
- Sponsor's protocol ID
- CP0109
- Status last verified
- Sep 2017
- First submitted
- 10 Sep 2014
- Last updated
- 24 Aug 2018
- 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 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light
- ClinicalTrials.gov ID
- NCT02239679
- Acronym / sponsor ID
- CP0109
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 21 Sep 2017
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 (AK) on the face, following treatment with liquid nitrogen cryotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALA X3 | Experimental | Drug: Aminolevulinic Acid, Device: BLU-U, Procedure: CryotherapyCryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments |
| VEH | Placebo comparator | Drug: Topical Solution Vehicle, Device: BLU-U, Procedure: CryotherapyVehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving cryotherapy and 2 or 3 subsequent Topical Solution Vehicle + BLU-U treatments. Subjects receiving VEH will be considered a single treatment group. |
| ALA X2 | Experimental | Drug: Aminolevulinic Acid, Device: BLU-U, Procedure: CryotherapyCryotherapy followed by 2 aminolevulinic acid + BLU-U treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Four to fifteen AKs on the face
- histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
- at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years
Key exclusion criteria (15 listed)
- Pregnancy
- 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
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 AcidAlso: Levulan Kerastick, ALA20% ALA applied to face for one hour prior to 10 J/cm2 blue light | Drug | ALA X2, ALA X3 |
| Topical Solution VehicleLevulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light | Drug | VEH |
| BLU-UAlso: BLU-U Blue Light Photodynamic Therapy Illuminator10 J/cm2 blue light delivered at 10 mW/cm2 | Device | ALA X2, ALA X3, VEH |
| CryotherapyAlso: Liquid NitrogenLiquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening. | Procedure or surgery | ALA X2, ALA X3, VEH |
Primary outcome
Total Number of AKs in Treatment Area
Time frame: Week 52
Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.
8 secondary outcomes
Proportion of Subjects With 0 AKs
Time frame: Week 4
Subject Satisfaction Score
Time frame: Week 52
Proportion of Subjects With 0 AKs
Time frame: Week 12
Proportion of Subjects With 0 AKs
Time frame: Week 24
Proportion of Subjects With 0 AKs
Time frame: Week 36
Proportion of Subjects With 0 AKs
Time frame: Week 52
Recurrence Rate
Time frame: Week 52
Duration of Response
Time frame: within 52 weeks after Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- 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.
8 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 Aminolevulinic Acid, BLU-U and Cryotherapy in people with Actinic Keratosis, run by DUSA Pharmaceuticals, Inc. at 8 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 3 inclusion and 15 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 21 Sep 2017). 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?
Total Number of AKs in Treatment Area (time frame: Week 52). 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 NCT02239679, 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 24 Aug 2018.