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Photosensitizer
Photodynamic Therapy for Actinic Keratosis
Phase 4
Waitlist Available
Research Sponsored by Goldman, Butterwick, Fitzpatrick and Groff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month12 post final pdt
Awards & highlights
Study Summary
This trial will compare the efficacy of two topical treatments for AKs, AMELUZ® gel and LEVULAN® KERASTICK®, using their respective light sources.
Who is the study for?
Adults aged 35-85 with mild to moderate Actinic Keratosis on hands/arms, who have an even number of lesions on both sides and skin type I-IV. Participants must consent to study procedures and use birth control if applicable. Excluded are those with recent clinical trial participation, photosensitizing medication use, certain skin conditions or treatments in the area, hypersensitivity to porphyrins or soybean phosphatidylcholine, excessive UV exposure, pregnancy/nursing/planning pregnancy.Check my eligibility
What is being tested?
The trial compares two photodynamic therapy treatments for Actinic Keratosis: AMELUZ gel (10%) with BF-RhodoLED lamp versus LEVULAN KERASTICK topical solution (20%) with BLU-U light. Each patient's one hand/arm side is treated with one method while the other side receives the alternative treatment.See study design
What are the potential side effects?
Potential side effects may include reactions at the application site such as redness, swelling, burning sensation; sensitivity to light; itching; changes in skin pigmentation; scarring; allergic reactions including hives and difficulty breathing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month12 post final pdt
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month12 post final pdt
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Lesion Clearance Rate
Secondary outcome measures
Clinical Recurrence
Cosmetic Outcome
Subject Satisfaction
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AmeluzExperimental Treatment1 Intervention
AMELUZ® (aminolevulinic acid hydrochloride) gel, 10% with its approved light source (BF-RhodoLED® lamp, 635 nm ± 9 nm, Biofrontera, Inc., Wakefield, MA, US)
Group II: LevulanActive Control1 Intervention
LEVULAN® KERASTICK® (aminolevulinic acid HCl) topical solution, 20% with its approved light source (BLU-U® Blue light photodynamic Therapy Illuminator Model 4170, 417 nm ± 5 nm, DUSA Pharmaceuticals, Wilmington MA, US)
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Who is running the clinical trial?
Biofrontera Bioscience GmbHIndustry Sponsor
10 Previous Clinical Trials
1,791 Total Patients Enrolled
Goldman, Butterwick, Fitzpatrick and GroffLead Sponsor
28 Previous Clinical Trials
570 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The number of growths or spots on each side of your body cannot be too different from each other.You have used medications that make your skin sensitive to sunlight in the past month.You have a wound, suspicious skin growth, scar, tattoo, or skin condition in the area where the treatment will be given.Your skin type is between very fair and light brown.You have had a treatment called PDT in the area where you want to receive the new treatment in the last 6 months.You have used oral or topical retinoids in the treatment area within the past month.You are overly sensitive to porphyrins.You have been diagnosed with porphyria or photodermatoses.You have mild to moderate AK lesions on both hands or arms, with 4 to 17 lesions in each treatment area.You have recently spent a lot of time in the sun or under UV lights in the treatment area.People between 35 and 85 years old, regardless of gender.You have had laser treatment on your arms within the last year.You had a light or medium skin peel on your arms in the last 30 days.You have had laser or light treatments on your arms in the last 3 months.You need to have a negative pregnancy test before starting the study, and then again on day 30 and day 60.The area to be treated should be able to receive light therapy using specific devices.
Research Study Groups:
This trial has the following groups:- Group 1: Ameluz
- Group 2: Levulan
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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