- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03322293
Daylight Photodynamic Therapy for Actinic Keratosis
Tolerability and Efficacy of Daylight Aminolevulinic-acid-photodynamic Therapy (ALA-PDT) Compared With Conventional ALA-PDT for Treatment of Actinic Keratosis on the Face or Scalp
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94115
- UCSF Dermatology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults at least 18 years old.
- Subjects must be able to read, sign, and understand the informed consent
- Subjects have at least 4 and no more than 20 clinically typical, visible actinic keratoses in the target treatment area on the face or scalp.
- Subject must be willing to forego any other treatments for AK in the treatment area on the face or scalp, during the study period, and for 14 days prior to screening; including cryotherapy, topical 5-fluorouracil, imiquimod, and ingenol mebutate.
- Subjects who have previously received PDT must undergo at least an 8-week washout period prior to enrollment in study.
- Subject must be willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions, and telephone interview.
- If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study. Women who are pregnant, lactating, or planning to become pregnant during the study period are excluded from the study.
Exclusion Criteria:
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
- Subjects with any medical condition that, in the opinion of the investigator, makes the patient unsuitable for the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A. Conventional arm
This is considered the standard of care arm for photodynamic therapy for the treatment of actinic keratosis. This treatment arm includes: Acetone preparation, ALA topical application, 1 hour incubation, 16 minutes 40 seconds (16:40) BLU-U exposure, application of sunscreen. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator |
PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent.
Subjects will receive ALA in all treatment arms (A, B, and C).
Depending on the treatment arm, subjects will either receive BLU-U exposure or not.
Treatment arms A and B have BLU-U exposure and treatment arm C does not.
|
Experimental: B. Combination arm
This treatment arm combines standard of care BLU-U exposure and daylight exposure. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, 16:40 BLU-U exposure, application of sunscreen, 45 minute daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: BLU-U blue light phototherapy illuminator |
PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent.
Subjects will receive ALA in all treatment arms (A, B, and C).
Depending on the treatment arm, subjects will either receive BLU-U exposure or not.
Treatment arms A and B have BLU-U exposure and treatment arm C does not.
|
Experimental: C. Daylight arm
This is the experimental arm. This treatment arm includes: Acetone preparation, ALA topical application, 15 minute incubation, application of sunscreen, 1 hour daylight exposure. Drug intervention: Aminolevulinic acid HCl (ALA) topical solution 20% Device: none |
PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent.
Subjects will receive ALA in all treatment arms (A, B, and C).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Treatment Symptoms
Time Frame: 12 weeks
|
Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus.
This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching.
Lower scores indicate less pain, burning/stinging, and itching/pruritus.
Positive numbers represent increases in symptoms and negative numbers represent decreases.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in AK Lesion Count
Time Frame: 12 weeks
|
The number of actinic keratoses within the treatment area was counted both pre and post-treatment.
Then, the mean percent change from baseline actinic keratosis lesion count was calculated for each treatment group.
|
12 weeks
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Reduction of AK Counts
Time Frame: 12 weeks
|
The number of AK lesions within the treatment area was assessed both pre and post-treatment.
Then, the number of participants with various levels of AK lesion reduction (100% reduction or greater than 75% reduction) was calculated for each treatment group.
This outcome measures the proportion of subjects with complete (100%) and partial (greater than or equal to 75%) reduction of baseline actinic keratosis lesion counts at 12 weeks (study end).
|
12 weeks
|
Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment
Time Frame: 12 weeks
|
To determine whether daylight PDT affords a reduction in local skin reaction to treatment.
A Local Skin Response Assessment scale will be used to measure this outcome.
The investigators will grade categories including Erythema, Flaking/Scaling, crusting, swelling, Pustulation (pustules), and Erosion, on a 0-4 scale (total maximum score of 24).
A higher score indicates more erythema, flaking, crusting, etc. and therefore a more robust skin reaction.
A score of 0 represents no erythema, flaking, crusting, etc.
|
12 weeks
|
Peak Pain Score at Day 8 Post-treatment
Time Frame: 8 days post-treatment
|
Pain was measured by patient report with a visual analog scale from 0-10.
0 indicates no pain and 10 indicates the maximum pain score.
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8 days post-treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah Arron, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Daylight PDT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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