Clinical Trial

A Long-term Safety and Efficacy Study of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Subjects With Acne Vulgaris (GEDACNE-LT)

Study acronym: GEDACNE-LT
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated March 11, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
Summary
The clinical trial aims to test the long term safety of a new drug for acne vulgaris. The trial is performed to answer this question "Is it safe to apply the IMP daily for up to 52 weeks?". The trial aims to accurately measure the safety and the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be review the drug containing the active ingredient. Participants will: * Take drug every day for up to 52 weeks * Visit the site once every 4 weeks for checkups and tests (where applicable) for the first 3 months of treatment, then visit the site every 13 weeks approximately for checkups and tests (where applicable). * Record on a diary the daily/weekly applications of the study drug at home, and record any adverse events
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-30.
Status change: Recruiting → Active, Not Recruiting 2026-03-10
Trial Details
NCT Number NCT07389109
Lead Sponsor PPM Services S.A.
Conditions Acne Vulgaris
Enrollment 400 participants
Start Date 2024-12-05
Primary Completion 2026-04 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-11