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

Stopped early · Phase 3

Conditions studied: Keratosis, Actinic

In brief

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

Key facts

Study ID

NCT04269395

Run by

Galderma R&D

People needed

125

Starts

2020-04-07

Expected to finish

2021-09-01

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Galderma Investigational Site (Site#8577) — Encinitas, California, United States
• Galderma Investigational Site (Site#8636) — Fountain Valley, California, United States
• Galderma Investigational Site (Site#8224) — Fremont, California, United States
• Galderma Investigational Site (Site#8778) — Denver, Colorado, United States
• Galderma Investigational Site (Site#8440) — Greenwood Village, Colorado, United States
• Galderma Investigational Site (Site#8479) — Bradenton, Florida, United States
• Galderma Investigational Site (Site#8769) — Lake Worth, Florida, United States
• Galderma Investigational Site (8770) — Lehigh Acres, Florida, United States
• Galderma Investigational Site (Site#8765) — North Miami Beach, Florida, United States
• Galderma Investigational Site (Site#8734) — Pembroke Pines, Florida, United States
• Galderma Investigational Site (Site#8529) — Sanford, Florida, United States
• Galderma Investigational Site (Site#8126) — West Palm Beach, Florida, United States
• Galderma Investigational Site (Site#8667) — Columbus, Georgia, United States
• Galderma Investigational Site (Site#8755) — Boise, Idaho, United States
• Galderma Investigational Site — Boise, Idaho, United States
• Galderma Investigational Site (Site#8838) — Darien, Illinois, United States
• Galderma Investigational Site (Site#8724) — Louisville, Kentucky, United States
• Galderma Investigational Site (Site#8208) — Beverly, Massachusetts, United States
• Galderma Investigational Site (Site#8574) — Clarkston, Michigan, United States
• Galderma Investigational Site (Site#8757) — Saint Joseph, Michigan, United States
• Galderma Investigational Site — Edina, Minnesota, United States
• Galderma Investigational Site — St Louis, Missouri, United States
• Galderma Investigational Site (Site#8048) — Omaha, Nebraska, United States
• Galderma Investigational Site 9Site#8420) — Portsmouth, New Hampshire, United States
• Galderma Investigational Site (Site#8447) — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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