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

Phase 3

Terminated

Conditions: Keratosis, Actinic

Interventions: Drug: MAL Cream
Drug: Vehicle cream

Registration Number: NCT04269395

Lead Sponsor: Galderma R&D

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

Detailed 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 & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 125

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAL Cream Arm	MAL Cream	Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.
Vehicle Cream Arm	Vehicle cream	Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (43): Galderma Investigational Site (Site#8447)
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Fort Smith, Arkansas, United States
Galderma Investigational Site (Site#8636)
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Fountain Valley, California, United States
Galderma Investigational Site (Site#8734)
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Pembroke Pines, Florida, United States
Galderma Investigational Site (Site#8576)
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Houston, Texas, United States
Galderma Investigational Site (Site#8779)
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Seattle, Washington, United States
Galderma Investigational Site (Site#8761)
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Salt Lake City, Utah, United States
Galderma Investigational Site (Site#8672)
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Salt Lake City, Utah, United States
Galderma Investigational Site (Site#8207)
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Nashville, Tennessee, United States
Galderma Investigational Site (Site#8529)
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Sanford, Florida, United States
Galderma Investigational Site (Site#8574)
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Clarkston, Michigan, United States
Galderma Investigational Site (Site#8126)
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West Palm Beach, Florida, United States
Galderma Investigational Site (Site#8224)
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Fremont, California, United States
Galderma Investigational Site (Site#8725)
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Morgantown, West Virginia, United States
Galderma Investigational Site (Site#8769)
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Lake Worth, Florida, United States
Galderma Investigational Site (Site#8667)
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Columbus, Georgia, United States
Galderma Investigational Site
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Sugarloaf, Pennsylvania, United States
Galderma Investigational Site (Site#8479)
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Bradenton, Florida, United States
Galderma Investigational Site (Site#8755)
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Boise, Idaho, United States
Galderma Investigational Site (Site#8838)
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Darien, Illinois, United States
Galderma Investigational Site (Site#8757)
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Saint Joseph, Michigan, United States
Galderma Investigational Site 9Site#8420)
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Portsmouth, New Hampshire, United States
Galderma Investigational Site (Site#8139)
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College Station, Texas, United States
Galderma Investigational Site 2(Site#8039)
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Spokane, Washington, United States
Galderma Investigational Site (Site#8440)
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Greenwood Village, Colorado, United States
Galderma Investigational Site (Site#8577)
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Encinitas, California, United States
Galderma Investigational Site (8770)
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Lehigh Acres, Florida, United States
Galderma Investigational Site (Site#8765)
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North Miami Beach, Florida, United States
Galderma Investigational Site (Site#8208)
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Beverly, Massachusetts, United States
Galderma Investigational Site (Site#8759)
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Albuquerque, New Mexico, United States
Galderma Investigational Site (Site#8595)
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Dublin, Ohio, United States
Galderma Investigational Site (Site#8664)
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Frisco, Texas, United States
Galderma Investigational Site (Site#8776)
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Saint George, Utah, United States
Galderma Investigational Site (Site#8546)
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Pflugerville, Texas, United States
Galderma Investigational Site (Site#8057)
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Lynchburg, Virginia, United States
Galderma Investigational Site (Site#8760)
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Spokane, Washington, United States
Galderma Investigational Site (Site#8566)
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Charlotte, North Carolina, United States
Galderma Investigational Site (Site#8231)
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Aibonito, Puerto Rico
Galderma Investigational Site (Site#8778)
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Denver, Colorado, United States
Galderma Investigational Site (Site#8724)
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Louisville, Kentucky, United States
Galderma Investigational Site (Site#8048)
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Omaha, Nebraska, United States
Galderma Investigational Site (Site#8212)
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Portland, Oregon, United States
Galderma Investigational Site (Site#8777)
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Charleston, South Carolina, United States
Galderma Investigational Site (Site#8076)
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Austin, Texas, United States