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NCT04085367 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
A Phase 3 study of Actinic Keratoses, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 557
- Enrollment target
- 20
- Study locations
NCT04085367: Completed Phase 3 study of Actinic Keratoses, sponsored by Galderma R&D.
NCT04085367 is a Phase 3 study of Actinic Keratoses that has completed, run by Galderma R&D. The registered enrollment target is 557 participants, above the 52-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (971% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04085367, a Phase 3 study of Actinic Keratoses, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 557 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
Primary Outcome
Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).
Conditions Studied
Interventions
- DRUG MAL 16.8% cream
- DRUG MAL Vehicle Cream
Study Locations (20)
Florida
- Galderma Investigational Site (Site 8479) - Bradenton
- Galderma Investigational Site (Site 8770) - Lehigh Acres
- Galderma Investigational Site (Site 8656) - Miami
- Galderma Investigational Site (Site 8765) - North Miami Beach
- Galderma Investigation Site (Site 8769) - Palm Springs
- Galderma Investigational Site (Site 8734) - Pembroke Pines
- Galderma Investigational Site (Site 8529) - Sanford
- Galderma Investigational Site (Site 8126) - West Palm Beach
California
- Galderma Investigational Site (Site 8577) - Encinitas
- Galderma Investigational Site (Site 8636) - Fountain Valley
- Galderma Investigational Site (Site 8224) - Fremont
- Galderma Investigational Site (Site 8114) - Fresno
- Galderma Investigational Site (Site 8758) - San Diego
- Galderma Investigational Site (Site 8608) - Santa Monica
Colorado
- Galderma Investigational Site (Site 8778) - Denver
- Galderma Investigational Site (Site 8440) - Greenwood Village
Georgia
- Galderma Investigational Site (Site 8683) - Atlanta
- Galderma Investigational Site (Site 8860) - Atlanta
Arizona
- Galderma Investigational Site (Site 8768) - Tucson
Arkansas
- Galderma Investigational Site (Site 8447) - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 557 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 3 |
What the finished NCT04085367 record still lists
NCT04085367 is an interventional study that assigns participants to a tested intervention. The registered 557 participants enrollment target is mid-sized for trials with a published cap, above the 52-participant average among 12 other Actinic Keratoses trials with a reported enrollment target (971% higher).
The record links to 1 condition, with Actinic Keratoses appearing as the primary indexed condition, and to 2 interventions - of which MAL 16.8% cream is the first listed.
NCT04085367 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04085367 about?
NCT04085367 is a clinical study titled "Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face". A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the fa...
What is the current status of trial NCT04085367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 557 participants. The study started on 2019-09-30. Estimated completion is 2021-04-07.
What conditions does trial NCT04085367 study?
This clinical trial studies the following conditions: Actinic Keratoses.
What interventions are being tested in trial NCT04085367?
The interventions under investigation include: MAL 16.8% cream (DRUG), MAL Vehicle Cream (DRUG).
Who is sponsoring clinical trial NCT04085367?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04085367 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04085367's enrollment target sits among peer trials
557 1st of 12 higher than 12 of 12 other Actinic Keratoses trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Actinic Keratoses trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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