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NCT04085367 Clinical Trial

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

Actinic Keratoses Clinical Trial

Official title:
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 (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04085367
Other study ID # RD.06.SPR.112199
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 30, 2019
Est. completion date April 7, 2021

Study information
Verified date March 2022
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.

Recruitment information / eligibility
Status Completed
Enrollment 557
Est. completion date April 7, 2021
Est. primary completion date March 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants aged = 18 years at the Screening visit. - Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp. - Female Participants of non-childbearing potential. - Participants fully understood and signed an ICF before any investigational procedure(s) are performed. Exclusion Criteria: - Participants with pigmented AK in the treatment areas. - Female participants who were pregnant, nursing, or planning a pregnancy during the study. - Participants with a clinical diagnosis of a skin disease other than AK. - Immunocompromised participants. - Participants with any condition that may be associated with a risk of poor protocol compliance.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MAL 16.8% cream
Day light photodynamic therapy with MAL 16.8% cream
• MAL Vehicle Cream
Day light photodynamic therapy with MAL vehicle cream

Locations
Country Name City State
Puerto Rico Galderma Investigational Site (Site 8231) Aibonito
United States Galderma Investigational Site (Site 8759) Albuquerque New Mexico
United States Galderma Investigational Site (Site 8683) Atlanta Georgia
United States Galderma Investigational Site (Site 8860) Atlanta Georgia
United States Galderma Investigational Site (Site 8076) Austin Texas
United States Galderma Investigational Site (Site 8208) Beverly Massachusetts
United States Galderma Investigational Site (Site 8755) Boise Idaho
United States Galderma Investigational Site (Site 8479) Bradenton Florida
United States Galderma Investigational Site (Site 8242) Brooklyn New York
United States Galderma Investigational Site (Site 8779) Burien Washington
United States Galderma Investigational Site (Site 8777) Charleston South Carolina
United States Galderma Investigational Site (Site 8566) Charlotte North Carolina
United States Galderma Investigational Site (Site 8574) Clarkston Michigan
United States Galderma Investigational Site (Site 8139) College Station Texas
United States Galderma Investigational Site (Site 8667) Columbus Georgia
United States Galderma Investigational Site (Site 8838) Darien Illinois
United States Galderma Investigational Site (Site 8778) Denver Colorado
United States Galderma Investigational Site (Site 8595) Dublin Ohio
United States Galderma Investigational Site (Site 8762) Edina Minnesota
United States Galderma Investigational Site (Site 8577) Encinitas California
United States Galderma Investigational Site (Site 8447) Fort Smith Arkansas
United States Galderma Investigational Site (Site 8636) Fountain Valley California
United States Galderma Investigational Site (Site 8224) Fremont California
United States Galderma Investigational Site (Site 8114) Fresno California
United States Galderma Investigational Site (Site 8664) Frisco Texas
United States Galderma Investigational Site (Site 8440) Greenwood Village Colorado
United States Galderma Investigational Site (Site # 8576) Houston Texas
United States Galderma Investigational Site (Site 8770) Lehigh Acres Florida
United States Galderma Investigational Site (Site 8724) Louisville Kentucky
United States Galderma Investigational Site (Site 8057) Lynchburg Virginia
United States Galderma Investigational Site (Site 8656) Miami Florida
United States Galderma Investigational Site (Site 8725) Morgantown West Virginia
United States Galderma Investigational Site (Site 8207) Nashville Tennessee
United States Galderma Investigational Site (Site 8140) New Brighton Minnesota
United States Galderma Investigational Site (Site 8279) New York New York
United States Galderma Investigational Site (Site 8733) New York New York
United States Galderma Investigational Site (Site 8765) North Miami Beach Florida
United States Galderma Investigational Site (Site 8048) Omaha Nebraska
United States Galderma Investigation Site (Site 8769) Palm Springs Florida
United States Galderma Investigational Site (Site 8734) Pembroke Pines Florida
United States Galderma Investigational Site (Site 8546) Pflugerville Texas
United States Galderma Investigational Site (Site 8255) Philadelphia Pennsylvania
United States Galderma Investigational Site (Site 8721) Pittsburgh Pennsylvania
United States Galderma Investiational Site (Site 8212) Portland Oregon
United States Galderma Investigational Site (Site 8420) Portsmouth New Hampshire
United States Galderma Investigational Site (Site 8776) Saint George Utah
United States Galderma Investigation Site (Site 8757) Saint Joseph Michigan
United States Galderma Investigational Site (Site 8219) Saint Louis Missouri
United States Galderma Investigational Site (Site 8869) Saint Louis Missouri
United States Galderma Investigational Site (Site 8672) Salt Lake City Utah
United States Galderma Investigational Site (Site 8758) San Diego California
United States Galderma Investigational Site (Site 8529) Sanford Florida
United States Galderma Investigational Site (Site 8608) Santa Monica California
United States Galderma Investigational Site (Site 8039) Spokane Washington
United States Galderma Investigational Site (Site 8760) Spokane Washington
United States Galderma Investigational Site (Site 8754) Sugarloaf Pennsylvania
United States Galderma Investigational Site (Site 8768) Tucson Arizona
United States Galderma Investigational Site (Site 8761) West Jordan Utah
United States Galderma Investigational Site (Site 8126) West Palm Beach Florida
United States Galderma Investigational Site (Site 8726) Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Complete Response at Week 12 Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT). Week 12
Secondary Percent Change From Baseline in Lesion Complete Response at Week 12 Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream. Baseline, Week 12
Secondary Percentage of Participants With Partial Response at Week 12 Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream. Week 12
See also
  Status Clinical Trial Phase
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Completed NCT02520700 - A Comparison of White-light and Daylight Topical Methyl 5-aminolaevulinic Acid Photodynamic Therapy for Actinic Keratoses N/A
Terminated NCT01538901 - Imiquimod Versus Photodynamic Therapy of Actinic Keratoses in Organ Transplant Recipients Phase 4
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