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
Verified date | September 2023 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States, Puerto Rico,
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 |
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