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
ClinicalTrials.gov processed this data on September 15, 2023. Link to the current ClinicalTrials.gov record.Recruitment Status
TERMINATED - HAS RESULTS(See Contacts and Locations)
Verified September 2023 by Galderma R&D
Sponsor
Galderma R&DInformation Provided by (Responsible Party)
Galderma R&DClinicaltrials.gov Identifier
NCT04269395Other Study ID Numbers: RD.06.SPR.115230
First Submitted: February 10, 2020
First Posted: February 13, 2020
Results First Posted: October 10, 2023
Last Update Posted: October 10, 2023
Last Verified: September 2023
History of Changes
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
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).Condition or Disease | Intervention/Treatment |
---|---|
|
|
Study Design
Study Type | Interventional |
---|---|
Actual Enrollment | 125 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | Double |
Primary Purpose | Prevention |
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 |
Study Start Date | April 7, 2020 |
Actual Primary Completion Date | September 1, 2021 |
Actual Study Completion Date | September 1, 2021 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
---|---|
|
|
|
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 [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.
Secondary Outcome Measures
- Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 [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.
- Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 [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.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
---|---|
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
|
Exclusion Criteria |
|
Contacts and Locations
Sponsors and Collaborators | Galderma R&D |
---|---|
Locations |
|
Study Documents (Full Text)
- Documents Provided by Galderma R&D: Study Protocol January 15, 2021
- Documents Provided by Galderma R&D: Statistical Analysis Plan September 29, 2021
More Information
Additional Relevant MeSH Terms
- Keratosis, Actinic
- Keratosis
- Recurrence
- Disease Attributes
- Pathologic Processes
- Skin Diseases
- Precancerous Conditions
- Neoplasms