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)
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
• Informed consent obtained: Written informed consent, before any study-related procedure, personally signed and dated by the patient if the patient is ≥ 18 years old, or signed and dated by the parents or the legal guardian(s) if the patient is ≥ 9 to \< 18 years old. An additional informed assent form must be signed by patient if ≥ 9 to \<18 years old to confirm his willingness to participate in the study. If the patient becomes 18 years of age during the study, the patient must provide written informed consent at that time to continue study participation
• Sex and age: Male and female patients aged ≥ 9 and \<50 years
• Diagnosis at screening and baseline visits:
‣ a) Patients affected by facial acne vulgaris with: Investigator's Global Assessment (IGA) score:
• equal to 3-4 if patient is \> 14 and \< 50 years old
∙ ≥ 2 if the patient is ≥ 9 and ≤ 14 years old. Face Inflammatory lesions: ≥ 20 and ≤ 100 inflammatory lesions (papules and pustules) and ≤ 1 nodules on the face. Face Non-inflammatory lesions: ≥ 20 and ≤ 100 non-inflammatory lesions (open and closed comedones) on the face
⁃ b) Patients affected also by truncal acne (optional criteria): The patient has a truncal acne on areas of the trunk (shoulders, upper back and upper anterior chest) accessible for patient's self-application of study medication with a severity grade equal to 2 or 3 on the Physician Global Assessment (PGA) scale. The patient has a minimum of 20 inflammatory lesions (papules and pustules) and 20 non-inflammatory lesions (open and closed comedones) but no more than 100 non-inflammatory lesions and no more than 100 inflammatory lesions and ≤ 1 nodules on areas of the trunk (shoulders, upper back and upper anterior chest) reachable to patient's self-application of study medication at screening and baseline.
• Full comprehension: Patients and their parents/legal guardian(s) (for \<18 years old patients) can comprehend the whole nature and purpose of the study, including possible risks and side effects, and are able to cooperate with the Investigator and to comply with the requirements of the entire study
• Contraception and fertility: Women of childbearing potential must be using an effective contraception method during the entire duration of the study (effective contraception methods are those considered at least acceptable according to CTFG Recommendations). A prior stable treatment period is required for the following reliable methods of contraception:
∙ Hormonal oral, implantable, transdermal, or injectable contraceptives must be stable for at least 6 months before the baseline visit
‣ A non-hormonal intrauterine device (IUD) must be started at least 2 months before the baseline visit.