Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
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
1 other identifier
interventional
235
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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
Shorter than P25 for phase_2
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
First Submitted
Initial submission to the registry
November 15, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
December 24, 2013
CompletedOctober 28, 2016
September 1, 2016
11 months
November 15, 2011
September 20, 2013
September 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Clearance Rate
The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Week 12
Secondary Outcomes (69)
Complete Clearance Rate
Week 4
Complete Clearance Rate
Week 8
Complete Clearance Rate
Week 24
Partial Clearance Rate
Baseline, Week 4
Partial Clearance Rate
Baseline, Week 8
- +64 more secondary outcomes
Study Arms (5)
Broad Area ALA 1-hour incubation
EXPERIMENTALBroad Area ALA 1-hour incubation
Broad Area ALA 2-hour incubation
EXPERIMENTALBroad Area ALA 2-hour incubation
Broad Area ALA 3-hour incubation
EXPERIMENTALBroad Area ALA 3-hour incubation
Spot ALA 2-hour incubation
EXPERIMENTALSpot ALA 2-hour incubation
Vehicle PDT
PLACEBO COMPARATORVEH 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.
Interventions
20% ALA, broad area, 1 hour incubation
20% ALA broad area 2-hour incubation
20% ALA broad area 3 hour incubation
20% ALA spot 2 hour incubation
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.
10 J/cm2 blue light delivered at 10 mW/cm2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
UCSD Dermatology Perlman Ambulatory Clinic
La Jolla, California, 92037, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, 45220, United States
Oregon Medical Research Center, PC
Portland, Oregon, 97223, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch, Inc.
Austin, Texas, 78759, 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
- Manager of Clinical Studies
- Organization
- DUSA Pharmaceuticals, Inc
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
November 15, 2011
First Posted
November 22, 2011
Study Start
December 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
October 28, 2016
Results First Posted
December 24, 2013
Record last verified: 2016-09