Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
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
1 other identifier
interventional
269
1 country
13
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 on the upper arms and hands
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2014
Shorter than P25 for phase_3
13 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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
September 16, 2015
CompletedSeptember 16, 2015
August 1, 2015
10 months
May 7, 2014
July 22, 2015
August 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Week 12
Secondary Outcomes (4)
AK Clearance Rate
Baseline and Week 12
AK Clearance Rate
Baseline and Week 8
Complete Clearance Rate
Week 8
Subject Satisfaction Score
Week 12
Other Outcomes (46)
Hyperpigmentation
Baseline
Hyperpigmentation
24-48 hours after PDT #1
Hyperpigmentation
2 Weeks after PDT #1
- +43 more other outcomes
Study Arms (2)
ALA
EXPERIMENTALVehicle
PLACEBO COMPARATORInterventions
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
10 J/cm2 blue light delivered at 10mW/cm2
Eligibility Criteria
You may qualify if:
- Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity
You may not qualify if:
- 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
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
UCSD Dermatology
San Diego, California, 92122, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
MOORE Clinical Research, Inc
Brandon, Florida, 33609, United States
Spencer Clinical Services
St. Petersburg, Florida, 33716, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
J&S Studies, Inc
College Station, Texas, 77845, 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 3
- 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
May 7, 2014
First Posted
May 14, 2014
Study Start
May 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
September 16, 2015
Results First Posted
September 16, 2015
Record last verified: 2015-08