Clinical trial

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

Name

RD.06.SPR.115230

Description

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

Trial arms

Trial start

2020-04-07

Estimated PCD

2021-09-01

Trial end

2021-09-01

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

MAL Cream Arm

Other names:

CD06809-41

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:

Vehicle Cream Arm

Size

125

Primary endpoint

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

At Week 54

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 125, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product