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

NCT07384208 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • PPM Services S.A.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384208 on ClinicalTrials.gov