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

Galderma

Status and phase: Terminated; Phase 3

Conditions: Keratosis, Actinic

Treatments: Drug: Vehicle cream; Drug: MAL Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04269395

RD.06.SPR.115230

Details and patient eligibility

About

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

Full 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).

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups, including a placebo group

MAL Cream Arm

Active Comparator group

Description:

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.

Treatment:

Drug: MAL Cream

Vehicle Cream Arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle cream