NCT07384208

A Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5% in Patients With Acne Vulgaris (GEDACNE 2)

A Phase III Study to Assess Efficacy and Safety of N-Acetyl-GED-0507-34-LEVO Gel 5%, Applied Once Daily for 12 Weeks in Patients With Acne Vulgaris (GEDACNE-2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: PPM Services S.A. · Academic / Other
• Sex: All
• Age: 9 Years – 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	N-Acetyl-GED-0507-34-Levo	Each patient will apply a fingertip unit of N-Acetyl-GED-0507-34-Levo 5% gel as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of the trunk accessible for self-application (i.e., shoulders, upper back, and upper anterior chest) for 12 consecutive weeks.
DRUG	N-Acetyl-GED-0507-34-Levo corresponding vehicle	Each patient will apply a fingertip unit of N-Acetyl-GED-0507-34-Levo corresponding vehicle as a thin film, once daily (OD), to the entire facial skin area and the affected skin areas of the trunk accessible for self-application (i.e., shoulders, upper back, and upper anterior chest) for 12 consecutive weeks.

Timeline

• Start date: 2024-11-19
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2026-02-03
• Last updated: 2026-03-11

Locations

31 sites across 3 countries: Italy, Poland, Spain