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NCT04269395 Clinical Trial

A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study

Keratosis, Actinic Clinical Trial

Official title:
A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or 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), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04269395
Other study ID # RD.06.SPR.115230
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 7, 2020
Est. completion date September 1, 2021

Study information
Verified date September 2023
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.

Description:

This is a double-blind, multicenter, long-term follow-up study. The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream (CD06809-41) or 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), for participants achieving complete response of treated lesions at Final Visit in Study RD.06.SPR.112199 (NCT04085367).

Recruitment information / eligibility
Status Terminated
Enrollment 125
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and achieved complete response at last visit - Participants fully understand and sign an informed consent form (ICF) before any study procedure begins - Participants willing and able to perform all study protocol requirements Exclusion Criteria: - Participants developing or experiencing any condition that may not be safe for them or not compliant will be excluded - Pertinent not compliant with study conditions or PI instructions during the earlier study - Lumexia Ph 3

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MAL Cream
No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
• Vehicle cream
No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.

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#8076) Austin Texas
United States Galderma Investigational Site (Site#8208) Beverly Massachusetts
United States Galderma Investigational Site Boise Idaho
United States Galderma Investigational Site (Site#8755) Boise Idaho
United States Galderma Investigational Site (Site#8479) Bradenton Florida
United States Galderma Investigational Site Brooklyn New York
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 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#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#8769) Lake Worth Florida
United States Galderma Investigational 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#8725) Morgantown West Virginia
United States Galderma Investigational Site (Site#8207) Nashville Tennessee
United States Galderma Investigational Site New York New York
United States Galderma Investigational Site New York New York
United States Galderma Investigational Site New York New York
United States Galderma Investigational Site 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 Investigational Site (Site#8734) Pembroke Pines Florida
United States Galderma Investigational Site (Site#8546) Pflugerville Texas
United States Galderma Investigational Site Philadelphia Pennsylvania
United States Galderma Investigational Site Pittsburgh Pennsylvania
United States Galderma Investigational Site (Site#8212) Portland Oregon
United States Galderma Investigational Site 9Site#8420) Portsmouth New Hampshire
United States Galderma Investigational Site (Site#8776) Saint George Utah
United States Galderma Investigational Site (Site#8757) Saint Joseph Michigan
United States Galderma Investigational Site Saint Louis Missouri
United States Galderma Investigational Site (Site#8672) Salt Lake City Utah
United States Galderma Investigational Site (Site#8761) Salt Lake City Utah
United States Galderma Investigational Site (Site#8529) Sanford Florida
United States Galderma Investigational Site (Site#8779) Seattle Washington
United States Galderma Investigational Site (Site#8760) Spokane Washington
United States Galderma Investigational Site 2(Site#8039) Spokane Washington
United States Galderma Investigational Site Sugarloaf Pennsylvania
United States Galderma Investigational Site (Site#8126) West Palm Beach Florida

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 Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 54 was reported. At Week 54
Secondary Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 Recurrence is defined as the percentage of recurrence of cleared treated lesions. Percent recurrence of cleared treated actinic keratosis lesions at Week 28 and Week 54 was reported. At Week 28 and Week 54
Secondary Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 28 was reported. At Week 28
See also
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Completed NCT02594644 - The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy N/A
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