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Photosensitizing Agent

MAL Cream Arm for Actinic Keratosis

Phase 3
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 28 and week 54
Awards & highlights

Study Summary

This trial is checking to see if the skin condition Actinic Keratosis comes back after being treated in an earlier study.

Eligible Conditions
  • Actinic Keratosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 28 and week 54
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 28 and week 54 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54
Secondary outcome measures
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28
Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MAL Cream ArmActive Control1 Intervention
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.
Group II: Vehicle Cream ArmPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,352 Total Patients Enrolled
~25 spots leftby May 2025
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