AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE LONG-TERM DERMAL SAFETY PROFILE OF 12-WEEKS TOPICAL ADMINISTRATION OF TWO DIFFERENT DOSES OF N-ACETYL-GED-0507-34-LEVO GEL IN PATIENTS WITH MILD TO MODERATE FACIAL ACNE

Phase 1

Conditions: Acne vulgaris
MedDRA version: 20.0Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2014-005244-17-IT

Lead Sponsor: PPM SERVICES S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

1.Written informed consent, personally signed and dated by the patient = 18 years old, or signed and dated by the parent(s) or the legal guardian if patient is <18 years old, prior to any study-related procedure. An additional assent form must be signed by the subject <18 years old to confirm his willingness to participate to the study.
2.Caucasian outpatients aged 14-30: 14-20 years old (Juvenile Acne) and 21-30 (Acne Tarda). Both males or females if patients = 18 years old, only males if patients < 18 years old.
3.Patients with mild to moderate acne defined by 2-3 score according to the Investigator Static Global Assessment (ISGA) of the cutaneous facial surface at the screening and baseline visits.
4.Patients having not more than 50 inflammatory lesions on the face (except the nose) and not more than one nodule
5.Patients having not more than 50 non-inflammatory lesions (open or closed comedones) on the face (except the nose) and not more than one nodule
6.Adult female patients not of childbearing potential; female patients of childbearing potential upon negative pregnancy testing at screening and who use effective method of birth control during the study and for one month after the last dose. In case of hormonal contraception it’s necessary that it has been established for at least 4 months before inclusion of the patient in the study;
7.Ability to understand and comply with study procedures and restrictions.

Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnant or breastfeeding women.
2.Patient with spontaneously improving or rapidly deteriorating acne within at least the past 3 months.
3.Patients who have a known history of acne unresponsive to topical treatments.
4.Subject with generalized or localized severe acne.
5.Not Caucasian subjects
6.Patient having beard or who intend to have beard grow during the study.
7.Subject with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with evaluation of acne, with the exception of footpad trichophytosis (athlete's foot).
8Subject with a history of an allergic reaction or significant sensitivity to constituents of study drug.
9Female patients of childbearing potential with hormonal contraception established or modified within 4 months before inclusion
10Patients who are using, will use during the study or discontinued less than 4 weeks prior inclusion topical therapies for the treatment of acne including but not limited to: corticosteroids, antibiotics, azelaic acid, benzoyl peroxide and retinoids.
11Patients who are using, will use during the study or discontinued less than 12 weeks prior inclusion phototherapy for the treatment of acne including but not limited to: UV-A, UV-B, eliotherapy.
12Patients who are using, will use during the study or discontinued less than 12 weeks prior inclusion systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin.
13Patients who had received any investigational chemical agents within at least 4 weeks or 5 half-lives prior to the baseline visit (whichever is longer).
14Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
15History of alcohol or other substance abuse within the last year.
16Patients potentially presenting poor reliability (e.g. bad mental conditions).
17Known or suspected hypersensitivity to any active or inactive ingredient in the study products.
18Patients who used another investigational agent or who took part in a clinical trial within the last 12 months prior first dose.