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Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face

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ClinicalTrials.gov Identifier: NCT04085367
Recruitment Status : Not yet recruiting
First Posted : September 11, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Brief Summary:
A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus 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)

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: MAL 16.8% cream Phase 3

Detailed Description:
This is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult subjects with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites will be selected to ensure that diverse daylight conditions will be represented in the study to understand the effects of latitude, elevation, and climate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : October 6, 2020
Estimated Study Completion Date : November 6, 2020


Arm Intervention/treatment
Placebo Comparator: Vehicle
Two treatments of Day light DLT two weeks apart
Drug: MAL 16.8% cream
Two treatments of DL-PDT
Other Name: Vehicle

Active Comparator: Treatment
Two treatments of Day light DLT two weeks apart
Drug: MAL 16.8% cream
Two treatments of DL-PDT
Other Name: Vehicle




Primary Outcome Measures :
  1. Lesion Response [ Time Frame: Week 12 ]
    Percent of lesions treated at 2nd DL-PDT in complete response at Week 12


Secondary Outcome Measures :
  1. Lesion Complete Response [ Time Frame: Week 12 ]
    Compare Lesion response between MAL and Vehicle DL-PDT

  2. Lesion Partial Response [ Time Frame: Week 12 ]
    Compare partial clearance of AK

  3. Subject Self-Assessment of Pain [ Time Frame: Week 12 ]
    Subject will assess maximum pain felt during day light exposure, where 0 - No Pain and 10 - Extreme Pain



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects aged ≥ 18 years at the Screening visit
  • Subjects have at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp
  • Female subjects of non-childbearing potential
  • Subject fully understands and signs an ICF before any investigational procedure(s) are performed

Exclusion Criteria:

  • Subjects with pigmented AK in the treatment areas
  • Female subjects who are pregnant, nursing, or planning a pregnancy during the study
  • Subjects with a clinical diagnosis of a skin disease other than AK
  • Immunocompromised subjects
  • Subjects with any condition that may be associated with a risk of poor protocol compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085367


Contacts
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Contact: Galderma

Sponsors and Collaborators
Galderma R&D

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04085367     History of Changes
Other Study ID Numbers: RD.06.SPR.112199
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents