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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
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.
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.
Azienda Ospedaliero Universitaria Delle Marche
Ancona, AN, Italy
Azienda USL Toscana Centro
Florence, FI, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
Azienda Ospedaliero Universitaria Parma
Parma, PR, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, RM, Italy
I.F.O. Istituti Fisioterapici Ospitalieri
Roma, RM, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Vitamed Galaj I Cichomski Sp. j.
Bydgoszcz, Poland
DERMAPOLIS Medical Dermatology Center dr n.med. Edyta Gebska
Chorzów, Poland
...and 19 more locations
The relative change from baseline in total lesion count (inflammatory plus non-inflammatory) at V5/Wk12 on the face
Time frame: From enrollment to the end of treatment at 12 weeks
Proportion of patients with an IGA success (face) at V5/Wk12.
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.
Time frame: From enrollment to the end of treatment at 12 weeks
Absolute change from baseline in total lesion count at V5/Wk12 (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Percentage of patients who achieve an IGA success over the study duration (face)
The Investigator Global Assessment (IGA) for acne is a 5-point clinical scale (0-4) used by dermatologists to assess overall acne severity based on lesion type and extent. It ranges from 0 (clear) to 4 (severe), providing a rapid, qualitative snapshot of facial acne, commonly used to measure treatment efficacy.
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in total lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in inflammatory lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in non-inflammatory lesion count over the study duration (face)
Time frame: From enrollment to the end of treatment at 12 weeks
Absolute change from baseline in total lesion count at V5/Wk12 (trunk)
Time frame: From enrollment to the end of treatment at 12 weeks
Percentage of patients who achieve a PGA score of 1 (almost clear) or 0 (clear) and at least a two-grade improvement from baseline over the study duration
The Physician Global Assessment (PGA) for acne is a standardized 5-point scale (0-4) used by clinicians to assess acne severity based on the number and type of lesions. It is frequently used in clinical trials and practice to measure treatment success, with a score of "clear" (0) or "almost clear" (1) usually indicating a successful outcome.
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal total lesion total count over the study duration
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal inflammatory lesion count over the study duration
Time frame: From enrollment to the end of treatment at 12 weeks
Change from baseline in truncal non-inflammatory lesion count over the study duration.
Time frame: From enrollment to the end of treatment at 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.