Evaluation of the efficacy and safety of a new gel for patients with acne vulgaris

Phase 1

Conditions: Acne vulgaris
MedDRA version: 17.1Level: PTClassification code 10000496Term: AcneSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-001491-62-SK

Lead Sponsor: AICONS Srl.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent: signed written informed consent before inclusion in the study
2.Sex and Age: men aged 18-50 years old inclusive
3.Diagnosis: moderate to severe facial acne with an IGA of 3-4 at screening and at baseline
4.Cutaneous lesions: 15=inflammatory lesions=70 located at or above the jawline
5.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
6.Contraception: willingness to use a barrier form of contraceptive with spermicidal foam/gel/film/cream/suppository throughout the study.

Are the trial subjects under 18? no
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 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Face skin conditions: face skin lesions other than acne lesions or local conditions preventing a correct evaluation of acne lesions (e.g. beard)
2.Nodulocystic acne: significant nodulocystic acne on the face i.e. =4 facial nodules defined as inflammatory lesions =0.5 cm in diameter and/or =1 facial cystic lesions defined as larger nodules undergoing suppuration
3.Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness; presence of abnormalities including alanine aminotransferase (ALT), aspartate aminotransferase (AST), ?-glutamyl transferase (?-GT), creatinine, urea and/or glucose values above 2x upper limit of normality (ULN) of the laboratory performing the analysis
4.Allergy: ascertained or presumptive hypersensitivity to antibiotics and/or to the test formulations' ingredients
5.Diseases: underlying severe renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin (excluding facial acne vulgaris), haematological, endocrine or neurological diseases including severe infections and viral diseases that may interfere with the aim of the study
6.Medications: systemic antibiotics, acne medications and/or light therapies in the month preceding the screening; topical antibiotics, antiseptics and/or acne medications in 2 weeks preceding the screening; continuous concurrent use of topical and/or systemic medications acting on or influencing acne
7.Investigative drug studies: participation in the evaluation of any investigational product within 30 days of the screening
8.Exposure to sun: inability and/or unwillingness to avoid excessive natural or artifical exposure to UV rays during the whole study duration

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to investigate the efficacy and the safety of NAI-Acne 3% gel in patients with moderate to severe facial acne applying the investigational product for 12 weeks in comparison with placebo. Efficacy of the NAI-Acne gel will be evaluated in terms of absolute and percent change in inflammatory lesion count (ILC), score reduction after investigator’s global assessment (IGA), absolute and percent change in total lesion count (TLC) and change in Cardiff acne disability index (CADI).;Secondary Objective: Not Applicable;Primary end point(s): 1. Absolute and percent change in ILC from baseline to week 12 compared between treatments;Timepoint(s) of evaluation of this end point: From baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. From baseline to weeks 4 and 8.<br>2. From baseline to weeks 4, 8 and 12.<br>3. From baseline to week 12.<br>4. From baseline to week 12.<br>5. During the whole duration of the study.;Secondary end point(s): 1. Absolute and percent change in ILC from baseline to weeks 4 and 8 compared between treatments;<br>2. Absolute and percent change in TLC from baseline to weeks 4, 8 and 12 compared between treatments;<br>3. Proportion of subjects with an IGA score reduction of at least 2 (defined as a success) from baseline to week 12 compared between treatments;<br>4. Change in CADI from baseline to week 12 compared between treatments;<br>5. Evaluation of safety, tolerability and local tolerability of the test treatment as compared to the matching placebo.<br>