Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities
Public ClinicalTrials.gov record NCT05359419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Photodynamic Therapy With Aminolevulinic Acid 10% Topical Gel Activated by Red Light Versus Aminolevulinic Acid 20% Topical Solution Activated by Blue Light for the Treatment of Actinic Keratosis on the Upper Extremities: A Blinded Randomized Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will be a prospective clinical trial performed in a single center, with 20 adult subjects presenting 4-17 clinically confirmed, mild to moderate AKs according to Olsen grading on each of two comparable treatment fields on the hands and/or arms of the patients. Subjects will be randomize to receive treatment on one side with AMELUZ® (aminolevulinic acid hydrochloride) gel, 10% with its approved light source (BF-RhodoLED® lamp, 635 nm ± 9 nm, Biofrontera, Inc., Wakefield, MA, US) and the other side with 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).
Study identification
- NCT ID
- NCT05359419
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Interventions
- aminolevulinic acid hydrochloride gel, 10% Combination Product
- aminolevulinic acid HCl topical solution, 20% Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 35 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2022
- Primary completion
- Aug 29, 2023
- Completion
- Dec 29, 2023
- Last update posted
- May 3, 2022
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cosmetic Laser Dermatology/West Dermatology Research Center | San Diego | California | 92121 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05359419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2022 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05359419 live on ClinicalTrials.gov.