A double-blind, randomized, vehicle-controlled clinical multi-center study to evaluate the efficacy and safety of N-Acetyl-GED-0507-34-LEVO gel, 2 and 5%, applied once daily for 12 weeks in patients with facial acne vulgaris

Phase 1

Conditions: facial acne vulgaris
MedDRA version: 20.0Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2018-003307-19-IT

Lead Sponsor: PPM SERVICES S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

Inclusion Criteria

1. 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 parent(s) or the legal guardian if the patient is = 12 to < 18 years old. An additional informed assent form must be signed by the patient if = 12 to <18 years old to confirm his willingness to participate in the study. If the patient becomes 8 years of age during the study, the patient must provide written informed consentat that time to continue study participation 2. Male and female patients aged = 12 to = 30 years old inclusive;3. Diagnosis: Patients with facial acne vulgaris with an investigator's global assessment (IGA) score of 3–4 at screening and baseline visits; 4. Inflammatory lesions: Patients with = 20 and =100 inflammatory lesions (papules and pustules) on the face (excluding the nose) and = 1 nodules; 5. Non-inflammatory lesions: Patients with = 20 and = 100 non-inflammatory lesions (open and closed comedones) on the face (excluding the nose); 6. Full comprehension: Patient and parent(s)/guardian for <18 years old patient's ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study; 7. Contraception and fertility: Women of childbearing potential must be using an effective contraception method during the entire duration of the study. 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 screening visit • A nonhormonal intrauterine device (IUD) must be started at least 2 months
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Pats with spontaneously improving or rapidly deteriorating acne within at least 3 months before study baseline. Pats who have a known history of acne unresponsive to topical and/or oral treatments. In particular subjects with history of persistent acne (a continuation of the
disease from adolescence into adulthood) and subjects with history of relapsing acne. Patients with generalized or localized acne forms other than acne vulgaris, e.g., acne conglobata, acne fulminans, acne rosacea,secondary acne (chloracne, drug-induced acne, etc), nodule-cystic acne,acne tarda or acne requiring systemic treatment. 2.Pats. who have abeard or who intend to grow a beard and/or to perform a facial tattoo during the study. Pat. has facial hair or facial tattoos that couldinterfere with the study assessments in the opinion of the investigator.3Pats with other active skin diseases or active skin infections in the facial region(bacterial, fungal, or viral) or any other facial disease or condition thatmight interfere with the evaluation of acne or place the pat. atunacceptable risk.4. Known or suspected hypersensitivity to or inactive ingredient in the study products. Pats with a history of an allergic reaction or significant sensitivity to the formulations' ingredients 5. Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the-counter topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide salicylates, a- hydroxy/glycolic acid, any other topical cosmetic therapy for acne and retinoids on the face. 6. Pats using, will use during the study, or discontinued less than 4 weeks before study baseline, facial application of products containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non-mild cleansers ormoisturizers containing retinol, salicylic or alpha- or beta-hydroxy acids,facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping). 7. Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, heliotherapy. Patients who have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the study. 8. Patients using, will use during the study, or discontinued less than12weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemictherapy which, in the opinion of the investigator, could affect thepatient's acne . 9. Known systemicdiseases that can lead to acneiform eruptions:10. Participation in the evaluation of any investigational product or device within 30 days before study baseline 11. Patient with underlying uncontrolled or unstable conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic,
endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator could significantly compromise the patient's safety and/or place the patient at an unacceptable risk. Any condition which in
the investigator's opinion would make it unsafe for the patient toparticipate in the study 12. History of alcohol or oth

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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