FACIAL ACNE MedDRA version: 20.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Product Name: N-Acetyl-GED-0507-34-Levo %5 gel
Product Code: NAC-GED-0507 5% GEL
Pharmaceutical Form: Gel
CAS Number: 1190427-41-8
Current Sponsor code: N-ACETYL-GED-0507-34-LEVO
Concentration unit: %
Sponsors
PPM SERVICES S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent and assent: 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 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Acne: Patients with spontaneously improving or rapidly deteriorating acne within at least 3 months before screening. Patients who have a known history of acne unresponsive to topical treatments. Patients with generalized or localized severe acne. Acne Conglobata, Acne Fulminans, Acne Rosacea, Secondary Acne (Chloracne, drug-induced acne, etc), Nodule-Cystic Acne, Acne requiring Systemic Treatment. 2. Beard and facial hair: Patients who have a beard or who intend to grow a beard during the study. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator 3. Skin diseases: Subjects with other active skin diseases (e.g. urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne, with the exception of footpad trichophytosis (athlete's foot) 4. Allergy: Known or suspected hypersensitivity to any active or inactive ingredient in the study products. Subjects with a history of an allergic reaction or significant sensitivity to the formulations’ ingredients 5. Topical therapies: 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 and retinoids. 6. Facial Procedures: facial application of products containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or alpha- or beta-hydroxy acids. Chemical or laser peel, micorderma abrasion, etc ) within the past 4 weeks or during the study 7. Phototherapy: 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 have the need or plan to be exposed to artificial tanning devices or excessive sunlight during the trial 8. Systemic therapies: Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne including but not limited to: antibiotics, isotretinoin. Other systemic therapy which, in the opinion of the investigator, could affect the subject’s acne (i.e. anabolics, lithium, EGRF inhibitors, iodides) 9. Sistemic diseases that can lead to acneiform eruptions: A) Increased Androgen Production. 1) Adrenal Origin: e.g Cushing’s Disease, 21-hydroxylase deficiency; 2) Ovarian origin: e.g. polycystic ovarian syndrome, ovarian hyperthecosis. B) Cryptococcosis Disseminated. C) Dimorphic fungal infections. D) Behçet’s Disease. 10. Investigative studies: Participation in the evaluation of any investigational product or device within 6 Months before study baseline 11. Diseases: Subject with underlying 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 immunocompromise the subject and/or place the subject at an unacceptable risk to receiving an immunomodulatory therapy. Any condition which in the investigator’s opinion would make it unsafe for the subject to participate in the study 12. Alcohol and other substance abuse: History of alcohol or other substance abuse within one year before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Local and systemic safety and tolerability of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to 5% gel in patients affected by facial acne vulgaris. Plasmatic concentration of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to the gel containing 5% of active principle ;Secondary Objective: Preliminary evaluation of efficacy of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to 5% gel in patients with facial acne vulgaris;Primary end point(s): Local and systemic safety and tolerability are the study primary end-points. Systemic safety and tolerability will be evaluated for all subjects exposed to at least one dose of study product, based on adverse events reported during the study and on monitoring of vital signs and laboratory results (haematology, biochemistry, urine). Local safety and tolerability will be evaluated on the facial surfaces treated with the investigational product on the basis of the following signs and symptoms: erythema, scaling, dryness and stinging/burning. For each of the symptoms and signs a severity score will be assigned using the following scale: 0: none; 1: mild; 2: moderate; 3: severe. Plasmatic pharmacokinetics after repeated topical exposures is a second primary objective. Plasmatic level of investigational product are measured after 12 weeks of treatment. Plasma concentration will be determined after the last dose in case of premature interruption of treatment, independently from the reason. Time intercourse between the last application of gel and plasma sample cannot be less than 4 hours ;Timepoint(s) of evaluation of this end point: Baseline Visit and at 3, 6, 9, 12 (End of Treatment) and 14 (Follow-up) weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Product efficacy will be evaluated: a) As changes from baseline of acne severity by IGA scale b) As changes from baseline of the overall count of acne lesions subdivided in: total, inflammatory (pustules and papules) and non-inflammatory (whiteheads and blackheads ¿ closed comedones and open comedones) c) As need of rescue medication from visit V3 (6¿ week) ;Timepoint(s) of evaluation of this end point: Baseline Visit and at 3, 6, 9, 12 (End of Treatment) and 14 (Follow-up) weeks | — |
Countries
Italy
Contacts
Public ContactMEDICAL DEPARTMENT
PPM SERVICES SA
Outcome results
None listed