Acne vulgaris 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 1% GEL
Pharmaceutical Form: Gel
CAS Number: 1190427-41-8
Current Sponsor code: N-ACETYL-GED-0507-34-LEVO
Other descriptive name: N-ACETYL-GED-0507-34-LEVO
Conce
Sponsors
PPM SERVICES S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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). 8 Subject with a history of an allergic reaction or significant sensitivity to constituents of study drug. 9 Female patients of childbearing potential with hormonal contraception established or modified within 4 months before inclusion 10 Patients 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. 11 Patients 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. 12 Patients 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. 13 Patients who had received any investigational chemical agents within at least 4 weeks or 5 half-lives prior to the baseline visit (whichever is longer). 14 Underlying 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. 15 History of alcohol or other substance abuse within the last year. 16 Patients potentially presenting poor reliability (e.g. bad mental conditions). 17 Known or suspected hypersensitivity to any active or inactive ingredient in the study products. 18 Patients who used another investigational agent or who took part in a clinical trial within the last 12 months prior first dose.
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 1% or 2% gel in patients with mild to moderate facial acne. Plasmatic concentration of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to the gel containing 1% or 2% of active principle. ;Secondary Objective: Preliminary evaluation of efficacy of N-Acetyl-GED-0507-34-Levo after 12 weeks repeated daily exposures to 1% or 2% gel in patients with mild to moderate facial acne.;Primary end point(s): 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, exfoliation, dryness and irritation (included signs of allergic contact dermatitis). For each of the symptoms and signs a severity score will be assigned using the following scale: 0: absent; 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 and at the end of the follow up i.e. two weeks after the end 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: day 1, day 21, day 42, day 84, day 98 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Product efficacy will be evaluated: a) As changes from baseline of acne severity by ISGA scale b) As changes from baseline of the overall count of acne lesions subdivided in: total, inflammatory (pustoles and comedones) and non-inflammatory (whiteheads and blackheads) c) As need of rescue medication from visit V3 (6° week) ;Timepoint(s) of evaluation of this end point: day 1, day 21, day 42, day 84, day 98 | — |
Countries
Italy
Contacts
Public ContactRegolatorio
Regulatory Pharma Net Srl
Outcome results
None listed