Clinical trial NCT04269395: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Keratosis, Actinic
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
timeFrame: At Week 54
Secondary outcomes:
measure: Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54
timeFrame: At Week 28 and Week 54
measure: Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28
timeFrame: At Week 28
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Galderma Investigational Site (Site#8447)
state: Arkansas
city: Encinitas
country: United States
facility: Galderma Investigational Site (Site#8577)
state: California
city: Fountain Valley
country: United States
facility: Galderma Investigational Site (Site#8636)
state: California
city: Fremont
country: United States
facility: Galderma Investigational Site (Site#8224)
state: California
city: Denver
country: United States
facility: Galderma Investigational Site (Site#8778)
state: Colorado
city: Greenwood Village
country: United States
facility: Galderma Investigational Site (Site#8440)
state: Colorado
city: Bradenton
country: United States
facility: Galderma Investigational Site (Site#8479)
state: Florida
city: Lake Worth
country: United States
facility: Galderma Investigational Site (Site#8769)
state: Florida
city: Lehigh Acres
country: United States
facility: Galderma Investigational Site (8770)
state: Florida
city: North Miami Beach
country: United States
facility: Galderma Investigational Site (Site#8765)
state: Florida
city: Pembroke Pines
country: United States
facility: Galderma Investigational Site (Site#8734)
state: Florida
city: Sanford
country: United States
facility: Galderma Investigational Site (Site#8529)
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Investigational Site (Site#8126)
state: Florida
city: Columbus
country: United States
facility: Galderma Investigational Site (Site#8667)
state: Georgia
city: Boise
country: United States
facility: Galderma Investigational Site (Site#8755)
state: Idaho
city: Boise
country: United States
facility: Galderma Investigational Site
state: Idaho
city: Darien
country: United States
facility: Galderma Investigational Site (Site#8838)
state: Illinois
city: Louisville
country: United States
facility: Galderma Investigational Site (Site#8724)
state: Kentucky
city: Beverly
country: United States
facility: Galderma Investigational Site (Site#8208)
state: Massachusetts
city: Clarkston
country: United States
facility: Galderma Investigational Site (Site#8574)
state: Michigan
city: Saint Joseph
country: United States
facility: Galderma Investigational Site (Site#8757)
state: Michigan
city: Edina
country: United States
facility: Galderma Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Galderma Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Galderma Investigational Site (Site#8048)
state: Nebraska
city: Portsmouth
country: United States
facility: Galderma Investigational Site 9Site#8420)
state: New Hampshire
city: Albuquerque
country: United States
facility: Galderma Investigational Site (Site#8759)
state: New Mexico
city: Brooklyn
country: United States
facility: Galderma Investigational Site
state: New York
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: Charlotte
country: United States
facility: Galderma Investigational Site (Site#8566)
state: North Carolina
city: Dublin
country: United States
facility: Galderma Investigational Site (Site#8595)
state: Ohio
city: Portland
country: United States
facility: Galderma Investigational Site (Site#8212)
state: Oregon
city: Philadelphia
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Sugarloaf
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site (Site#8777)
state: South Carolina
city: Nashville
country: United States
facility: Galderma Investigational Site (Site#8207)
state: Tennessee
city: Austin
country: United States
facility: Galderma Investigational Site (Site#8076)
state: Texas
city: College Station
country: United States
facility: Galderma Investigational Site (Site#8139)
state: Texas
city: Frisco
country: United States
facility: Galderma Investigational Site (Site#8664)
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site (Site#8576)
state: Texas
city: Pflugerville
country: United States
facility: Galderma Investigational Site (Site#8546)
state: Texas
city: Saint George
country: United States
facility: Galderma Investigational Site (Site#8776)
state: Utah
city: Salt Lake City
country: United States
facility: Galderma Investigational Site (Site#8761)
state: Utah
city: Salt Lake City
country: United States
facility: Galderma Investigational Site (Site#8672)
state: Utah
city: Lynchburg
country: United States
facility: Galderma Investigational Site (Site#8057)
state: Virginia
city: Seattle
country: United States
facility: Galderma Investigational Site (Site#8779)
state: Washington
city: Spokane
country: United States
facility: Galderma Investigational Site (Site#8760)
state: Washington
city: Spokane
country: United States
facility: Galderma Investigational Site 2(Site#8039)
state: Washington
city: Morgantown
country: United States
facility: Galderma Investigational Site (Site#8725)
state: West Virginia
city: Aibonito
country: Puerto Rico
facility: Galderma Investigational Site (Site#8231)
Study officials:
References: