TerminatedPhase 3

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: The study was terminated early as per Sponsor's decision

United States125 participantsStarted 2020-04-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54

Timeframe: At Week 54

Trial details

NCT IDNCT04269395

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-01

Results submitted2023-05-27

View on ClinicalTrials.gov More Keratosis, Actinic trials