NCT07389109

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

• 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 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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	N-Acetyl-GED-0507-34-LEVO gel 5%	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 up to 52 consecutive weeks.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2026-02-05
• Last updated: 2026-03-11

Locations

59 sites across 3 countries: Italy, Poland, Spain