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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-1)
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
Details
| Lead sponsor | PPM Services S.A. |
|---|---|
| Phase | Phase 3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 400 |
| Start date | 2024-11-19 |
| Completion | 2026-03 |
Conditions
- Acne Vulgaris
Interventions
- N-Acetyl-GED-0507-34-Levo 5% gel
- N-Acetyl-GED-0507-34-Levo corresponding vehicle
Primary outcomes
- The relative change from baseline in total lesion count (inflammatory plus non-inflammatory) at V5/Wk12 on the face — From enrollment to the end of treatment at 12 weeks
- Proportion of patients with an IGA success (face) at V5/Wk12. — From enrollment to the end of treatment at 12 weeks
IGA success is defined according to the patient's age as: * a score of "clear" (score = 0) or "almost clear" (score = 1) for patients aged ≥ 9 and ≤ 14 years * a score of "clear" (score = 0) or "almost clear" (score = 1) in IGA at V5/Wk12 for patients aged \> 14 and \< 50 years.
Countries
Italy, Poland, Spain