Clinical trial NCT04085367: Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratoses
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 557
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus 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).

Detailed description: This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.

Eligibility criteria: Inclusion Criteria:

* Participants aged ≥ 18 years at the Screening visit.
* Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.
* Female Participants of non-childbearing potential.
* Participants fully understood and signed an ICF before any investigational procedure(s) are performed.

Exclusion Criteria:

* Participants with pigmented AK in the treatment areas.
* Female participants who were pregnant, nursing, or planning a pregnancy during the study.
* Participants with a clinical diagnosis of a skin disease other than AK.
* Immunocompromised participants.
* Participants with any condition that may be associated with a risk of poor protocol compliance.

Primary outcomes:
measure: Percentage of Participants With Complete Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Lesion Complete Response at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants With Partial Response at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Galderma Investigational Site (Site 8768)
state: Arizona
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: Fresno
country: United States
facility: Galderma Investigational Site (Site 8114)
state: California
city: San Diego
country: United States
facility: Galderma Investigational Site (Site 8758)
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational Site (Site 8608)
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: Lehigh Acres
country: United States
facility: Galderma Investigational Site (Site 8770)
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site (Site 8656)
state: Florida
city: North Miami Beach
country: United States
facility: Galderma Investigational Site (Site 8765)
state: Florida
city: Palm Springs
country: United States
facility: Galderma Investigation Site (Site 8769)
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: Atlanta
country: United States
facility: Galderma Investigational Site (Site 8683)
state: Georgia
city: Atlanta
country: United States
facility: Galderma Investigational Site (Site 8860)
state: Georgia
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: 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 Investigation Site (Site 8757)
state: Michigan
city: Edina
country: United States
facility: Galderma Investigational Site (Site 8762)
state: Minnesota
city: New Brighton
country: United States
facility: Galderma Investigational Site (Site 8140)
state: Minnesota
city: Saint Louis
country: United States
facility: Galderma Investigational Site (Site 8219)
state: Missouri
city: Saint Louis
country: United States
facility: Galderma Investigational Site (Site 8869)
state: Missouri
city: Omaha
country: United States
facility: Galderma Investigational Site (Site 8048)
state: Nebraska
city: Portsmouth
country: United States
facility: Galderma Investigational Site (Site 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 (Site 8242)
state: New York
city: New York
country: United States
facility: Galderma Investigational Site (Site 8733)
state: New York
city: New York
country: United States
facility: Galderma Investigational Site (Site 8279)
state: New York
city: Charlotte
country: United States
facility: Galderma Investigational Site (Site 8566)
state: North Carolina
city: Wilmington
country: United States
facility: Galderma Investigational Site (Site 8726)
state: North Carolina
city: Dublin
country: United States
facility: Galderma Investigational Site (Site 8595)
state: Ohio
city: Portland
country: United States
facility: Galderma Investiational Site (Site 8212)
state: Oregon
city: Philadelphia
country: United States
facility: Galderma Investigational Site (Site 8255)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Galderma Investigational Site (Site 8721)
state: Pennsylvania
city: Sugarloaf
country: United States
facility: Galderma Investigational Site (Site 8754)
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 8672)
state: Utah
city: West Jordan
country: United States
facility: Galderma Investigational Site (Site 8761)
state: Utah
city: Lynchburg
country: United States
facility: Galderma Investigational Site (Site 8057)
state: Virginia
city: Burien
country: United States
facility: Galderma Investigational Site (Site 8779)
state: Washington
city: Spokane
country: United States
facility: Galderma Investigational Site (Site 8039)
state: Washington
city: Spokane
country: United States
facility: Galderma Investigational Site (Site 8760)
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: