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

Overview

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

Full Title of Study: “A Double-blind, Multicenter, Long-term Follow-up Study to Assess Recurrence of Actinic Keratosis in Subjects Treated With Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) or 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), for Subjects Achieving Complete Response of Treated Lesions at Final Visit in Study RD.06.SPR.112199″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 31, 2021

Detailed Description

This is a double-blind, multicenter, long-term follow-up study. The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream (CD06809-41) or 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), for participants achieving complete response of treated lesions at Final Visit in Study RD.06.SPR.112199 (NCT04085367).

Interventions

  • Drug: MAL Cream
    • 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.
  • Drug: Vehicle cream
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: MAL Cream Arm
    • 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.
  • Placebo Comparator: Vehicle Cream Arm
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Participants with Recurrence of Any (>=1) Cleared Treated Actinic Keratosis (AK) Lesions at Visit 3
    • Time Frame: VIsit 3 (52 weeks after last DL-PDT treatment)
    • Proportion of participants with recurrence of any (greater than or equal to [>=]1) cleared treated AK lesions at Visit 3 that is 52 weeks after the last daylight photodynamic therapy (DL-PDT) treatment will be reported.

Secondary Measures

  • Lesion Recurrence
    • Time Frame: Visits 2 and 3 (26 and 52 weeks after the last DL-PDT treatment )
    • Lesion recurrence (percentage of cleared treated lesions) at Visits 2 and 3 after the last DL-PDT treatment will be reported.
  • Proportion of Participants with Recurrence of Any (>=1) Cleared Treated AK Lesions at Visit 2
    • Time Frame: VIsit 2 (26 weeks after last DL-PDT treatment)
    • Proportion of participants with recurrence of any (>=1) cleared treated AK lesions at Visit 2 that is 26 weeks after the last DL-PDT treatment will be reported.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma R&D
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Galderma Research & Development, 817-961-5000, clinical.studies@galderma.com

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