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

NCT04269395 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: RD.06.SPR.115230
• Study Type: interventional
• Target: 125
• Locations: 2 countries
• Sites: 53

Brief Summary

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

Conditions

Keratosis, Actinic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54

  At Week 28 and Week 54

• Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28

  At Week 28

Study Arms (2)

MAL Cream Arm

ACTIVE COMPARATOR

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.

Drug: MAL Cream

Vehicle Cream Arm

PLACEBO COMPARATOR

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.

Drug: Vehicle cream

Interventions

MAL Cream DRUG

No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.

Also known as: CD06809-41

MAL Cream Arm

Vehicle cream DRUG

No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.

Vehicle Cream Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (53)

Galderma Investigational Site (Site#8447)

Fort Smith, Arkansas, 72916, 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#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#8769)

Lake Worth, Florida, 33461, United States

Location

Galderma Investigational Site (8770)

Lehigh Acres, Florida, 33936, United States

Location

Galderma Investigational Site (Site#8765)

North Miami Beach, Florida, 33162, 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#8667)

Columbus, Georgia, 31904, United States

Location

Galderma Investigational Site (Site#8755)

Boise, Idaho, 83704, United States

Location

Galderma Investigational Site

Boise, Idaho, 83713, 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, United States

Location

Galderma Investigational Site (Site#8757)

Saint Joseph, Michigan, 49085, United States

Location

Galderma Investigational Site

Edina, Minnesota, 55410, United States

Location

Galderma Investigational Site

St Louis, Missouri, 63141, United States

Location

Galderma Investigational Site (Site#8048)

Omaha, Nebraska, 68144, United States

Location

Galderma Investigational Site 9Site#8420)

Portsmouth, New Hampshire, 03801, United States

Location

Galderma Investigational Site (Site#8759)

Albuquerque, New Mexico, 87102, United States

Location

Galderma Investigational Site

Brooklyn, New York, 11209, United States

Location

Galderma Investigational Site

New York, New York, 10010, United States

Location

Galderma Investigational Site

New York, New York, 10022, United States

Location

Galderma Investigational Site

New York, New York, 10029-6501, United States

Location

Galderma Investigational Site

New York, New York, 10075, United States

Location

Galderma Investigational Site (Site#8566)

Charlotte, North Carolina, 28277, United States

Location

Galderma Investigational Site (Site#8595)

Dublin, Ohio, 43016, United States

Location

Galderma Investigational Site (Site#8212)

Portland, Oregon, 97210, United States

Location

Galderma Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

Galderma Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Galderma Investigational Site

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, United States

Location

Galderma Investigational Site (Site#8761)

Salt Lake City, Utah, 84101, 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#8057)

Lynchburg, Virginia, 24501, United States

Location

Galderma Investigational Site (Site#8779)

Seattle, Washington, 98168, United States

Location

Galderma Investigational Site (Site#8760)

Spokane, Washington, 99202, United States

Location

Galderma Investigational Site 2(Site#8039)

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

Limitations and Caveats

This LTFU study was terminated early by the Sponsor because in the main study RD.06.SPR.112199, the primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT in terms of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

8179615000

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: April 7, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Locations

US (52); PR (1)