Clinical Trial

A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, in Patients With Acne Vulgaris (GEDACNE-1)

Study acronym: GEDACNE-1
Active, Not Recruiting Phase 3
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Summary
The clinical trial aims to test a new drug for acne vulgaris. The trial is performed to answer this question "Is it possible to reduce the number of skin lesions on your face/trunk, after daily applications for 12 consecutive weeks of a new drug?". The trial aims to accurately measure the effects of the new treatment (N-Acetyl-GED-0507-34-LEVO gel 5%) and to achieve this, patients will be randomly assigned to one of the following treatments: * Study drug 1: test item, containing active ingredient * Study drug 2: a preparation not containing any active ingredient (vehicle). Researchers will compare active to vehicle to see if there are differences in the efficacy. Participants will: * Apply drug or a placebo every day for 12 weeks * Visit the site once every 4 weeks for checkups and tests (where applicable) * Record on a diary the daily applications of the study drug at home, and record any adverse events
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-26; most recent amendment 2026-03-10.
Status change: Recruiting → Active, Not Recruiting 2026-03-10
Trial Details
NCT Number NCT07384195
Lead Sponsor PPM Services S.A.
Conditions Acne Vulgaris
Enrollment 400 participants
Start Date 2024-11-19
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-11