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COMPLETED 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

NCT04085367 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 557 participants
Start Date 2019-09-30
Est. Completion 2021-04-07
Phase Phase 3

Sponsor

Galderma R&D

49 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04085367

The ClinicalTrials.gov registry entry for NCT04085367 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 557 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04085367 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04085367?

The interventions under investigation include: MAL 16.8% cream (DRUG), MAL Vehicle Cream (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04085367?

This trial is sponsored by Galderma R&D, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial