NCT04269395

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-07
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-02-13
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

53 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study