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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

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ClinicalTrials.gov Identifier: NCT04269395
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

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

Condition or disease Intervention/treatment Phase
Keratosis, Actinic Drug: MAL Cream Drug: Vehicle cream Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : November 28, 2021
Estimated Study Completion Date : April 14, 2022

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Arm Intervention/treatment
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.
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.
Other Name: CD06809-41

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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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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:

  • 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

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): NCT04269395


Contacts
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Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com

Locations
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Sponsors and Collaborators
Galderma R&D
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04269395    
Other Study ID Numbers: RD.06.SPR.115230
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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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
Recurrence
Disease Attributes
Pathologic Processes
Skin Diseases
Precancerous Conditions
Neoplasms