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

NCT04085367 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RD.06.SPR.112199
• Study Type: interventional
• Target: 557
• Locations: 2 countries
• Sites: 60

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).

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Response at Week 12

  Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).

  Week 12

Secondary Outcomes (2)

• Percent Change From Baseline in Lesion Complete Response at Week 12

  Baseline, Week 12

• Percentage of Participants With Partial Response at Week 12

  Week 12

Study Arms (2)

MAL 16.8% Cream

EXPERIMENTAL

Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \[DL-PDT\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.

Drug: MAL 16.8% cream

MAL Vehicle Cream

PLACEBO COMPARATOR

Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.

Drug: MAL Vehicle Cream

Interventions

MAL 16.8% cream DRUG

Day light photodynamic therapy with MAL 16.8% cream

Also known as: CD06809-41

MAL 16.8% Cream

MAL Vehicle Cream DRUG

Day light photodynamic therapy with MAL vehicle cream

MAL Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (60)

Galderma Investigational Site (Site 8768)

Tucson, Arizona, 85718, United States

Location

Galderma Investigational Site (Site 8447)

Fort Smith, Arkansas, 72916-6103, United States

Location

Galderma Investigational Site (Site 8577)

Encinitas, California, 92024, United States

Location

Galderma Investigational Site (Site 8636)

Fountain Valley, California, 92708, United States

Location

Galderma Investigational Site (Site 8224)

Fremont, California, 94538, United States

Location

Galderma Investigational Site (Site 8114)

Fresno, California, 93720, United States

Location

Galderma Investigational Site (Site 8758)

San Diego, California, 92121, United States

Location

Galderma Investigational Site (Site 8608)

Santa Monica, California, 90404, United States

Location

Galderma Investigational Site (Site 8778)

Denver, Colorado, 80210, United States

Location

Galderma Investigational Site (Site 8440)

Greenwood Village, Colorado, 80111, United States

Location

Galderma Investigational Site (Site 8479)

Bradenton, Florida, 34209, United States

Location

Galderma Investigational Site (Site 8770)

Lehigh Acres, Florida, 33936, United States

Location

Galderma Investigational Site (Site 8656)

Miami, Florida, 33137, United States

Location

Galderma Investigational Site (Site 8765)

North Miami Beach, Florida, 33162, United States

Location

Galderma Investigation Site (Site 8769)

Palm Springs, Florida, 33461, United States

Location

Galderma Investigational Site (Site 8734)

Pembroke Pines, Florida, 33028, United States

Location

Galderma Investigational Site (Site 8529)

Sanford, Florida, 32771, United States

Location

Galderma Investigational Site (Site 8126)

West Palm Beach, Florida, 33401, United States

Location

Galderma Investigational Site (Site 8683)

Atlanta, Georgia, 30342-1418, United States

Location

Galderma Investigational Site (Site 8860)

Atlanta, Georgia, 30342, United States

Location

Galderma Investigational Site (Site 8667)

Columbus, Georgia, 31904, United States

Location

Galderma Investigational Site (Site 8755)

Boise, Idaho, 83704, United States

Location

Galderma Investigational Site (Site 8838)

Darien, Illinois, 60561, United States

Location

Galderma Investigational Site (Site 8724)

Louisville, Kentucky, 40241, United States

Location

Galderma Investigational Site (Site 8208)

Beverly, Massachusetts, 01915, United States

Location

Galderma Investigational Site (Site 8574)

Clarkston, Michigan, 48346-3198, United States

Location

Galderma Investigation Site (Site 8757)

Saint Joseph, Michigan, 49085, United States

Location

Galderma Investigational Site (Site 8762)

Edina, Minnesota, 55424-1200, United States

Location

Galderma Investigational Site (Site 8140)

New Brighton, Minnesota, 55112, United States

Location

Galderma Investigational Site (Site 8219)

St Louis, Missouri, 63141, United States

Location

Galderma Investigational Site (Site 8869)

St Louis, Missouri, 63141, United States

Location

Galderma Investigational Site (Site 8048)

Omaha, Nebraska, 68144, United States

Location

Galderma Investigational Site (Site 8420)

Portsmouth, New Hampshire, 03801, United States

Location

Galderma Investigational Site (Site 8759)

Albuquerque, New Mexico, 87102, United States

Location

Galderma Investigational Site (Site 8242)

Brooklyn, New York, 11203, United States

Location

Galderma Investigational Site (Site 8733)

New York, New York, 10022, United States

Location

Galderma Investigational Site (Site 8279)

New York, New York, 10075, United States

Location

Galderma Investigational Site (Site 8566)

Charlotte, North Carolina, 28277, United States

Location

Galderma Investigational Site (Site 8726)

Wilmington, North Carolina, 28405-3176, United States

Location

Galderma Investigational Site (Site 8595)

Dublin, Ohio, 43016, United States

Location

Galderma Investiational Site (Site 8212)

Portland, Oregon, 97210-2996, United States

Location

Galderma Investigational Site (Site 8255)

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site (Site 8721)

Pittsburgh, Pennsylvania, 15213, United States

Location

Galderma Investigational Site (Site 8754)

Sugarloaf, Pennsylvania, 18249, United States

Location

Galderma Investigational Site (Site 8777)

Charleston, South Carolina, 29407, United States

Location

Galderma Investigational Site (Site 8207)

Nashville, Tennessee, 37215, United States

Location

Galderma Investigational Site (Site 8076)

Austin, Texas, 78759, United States

Location

Galderma Investigational Site (Site 8139)

College Station, Texas, 77845, United States

Location

Galderma Investigational Site (Site 8664)

Frisco, Texas, 75034, United States

Location

Galderma Investigational Site (Site # 8576)

Houston, Texas, 77056, United States

Location

Galderma Investigational Site (Site 8546)

Pflugerville, Texas, 78660-3519, United States

Location

Galderma Investigational Site (Site 8672)

Salt Lake City, Utah, 84117, United States

Location

Galderma Investigational Site (Site 8776)

St. George, Utah, 84790, United States

Location

Galderma Investigational Site (Site 8761)

West Jordan, Utah, 84101, United States

Location

Galderma Investigational Site (Site 8057)

Lynchburg, Virginia, 24501, United States

Location

Galderma Investigational Site (Site 8779)

Burien, Washington, 98168, United States

Location

Galderma Investigational Site (Site 8039)

Spokane, Washington, 99202, United States

Location

Galderma Investigational Site (Site 8760)

Spokane, Washington, 99202, United States

Location

Galderma Investigational Site (Site 8725)

Morgantown, West Virginia, 26505, United States

Location

Galderma Investigational Site (Site 8231)

Aibonito, 00705, Puerto Rico

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: September 30, 2019
• Primary Completion: March 3, 2021
• Study Completion: April 7, 2021
• Last Updated: April 1, 2022
• Results First Posted: April 1, 2022

Record last verified: 2022-03

Locations

PR (1); US (59)