Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
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
1 other identifier
interventional
166
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 10, 2014
CompletedFirst Posted
Study publicly available on registry
September 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
September 21, 2017
CompletedAugust 24, 2018
September 1, 2017
1.8 years
September 10, 2014
August 16, 2017
July 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 52
Secondary Outcomes (8)
Proportion of Subjects With 0 AKs
Week 4
Subject Satisfaction Score
Week 52
Proportion of Subjects With 0 AKs
Week 12
Proportion of Subjects With 0 AKs
Week 24
Proportion of Subjects With 0 AKs
Week 36
- +3 more secondary outcomes
Other Outcomes (60)
Hyperpigmentation
Screening
Hyperpigmentation
Baseline
Hyperpigmentation
24-48 hours after photodynamic therapy (PDT) #1
- +57 more other outcomes
Study Arms (3)
ALA X3
EXPERIMENTALCryotherapy followed by 3 aminolevulinic acid + blue light (BLU-U) treatments
VEH
PLACEBO COMPARATORVehicle (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
EXPERIMENTALCryotherapy followed by 2 aminolevulinic acid + BLU-U treatments
Interventions
20% ALA applied to face for one hour prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
10 J/cm2 blue light delivered at 10 mW/cm2
Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
UCSD Dermatology
San Diego, California, 92122, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
Sadick Research Group
New York, New York, 10075, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, 77056, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
Related Publications (1)
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.
PMID: 38125671DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Houlihan
- Organization
- DUSA Pharmaceuticals Inc., a Sun Pharma Co.
Study Officials
- STUDY DIRECTOR
Stuart Marcus, MD, PhD
DUSA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2014
First Posted
September 15, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
August 24, 2018
Results First Posted
September 21, 2017
Record last verified: 2017-09