MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE THERAPY WITH THE COMBINATION OF BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% W/W FOR THE TOPICAL TREATMENT OF ACNE VULGARIS

• Conditions: ACNE VULGARIS

• Registration Number: EUCTR2009-016240-40-GR
• Lead Sponsor: VERISFIELD (UK) LTD, GREEK BRANCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- PATIENTS WITH MILD TO MODERATE ACNE VULGARIS
- MALE AND FEMALE PATIENTS AGED 12-35 YEARS
- MALES AND FEMALES WHO ARE CONSIDERED HEALTHY
- FEMALE PATIENTS WHO DO NOT SHOW ANY SIGNS OF HYPERANDROG?NISM
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- PATIENTS WHO HAVE PARTICIPATED OR CURRENTLY PARTICIPATING TO ANOTHER STUDY
- PATIENTS ON TOPICAL OR SYSTEMIC TREATMENT FOR ACNE VULGARIS
- PATIENTS WHO RECEIVE DRUGS THAT MIGHT INFLUENCE THE FINDINGS OF THE STUDY
- PATIENTS WITH CARDIOVASCULAR, NEOPLASMATIC, HAEMATOLOGICAL, HEPATIC, NEUROLOGICAL, RENAL, ENDOCRINE AND GASTROENTEROLOGICAL DISEASE
- PATIENTS WITH A DERMATOLOGICAL LESION IN THE AREA (OR IN CLOSE PROXIMITY e.g. 3cm) TO BE TREATED
- PREGNANT OR LACTATING PATIENTS
- FEMALE PATIENTS IN REPRODUCTIVE AGE WHO DO NOT USE ADEQUATE CONTRACEPTION

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: THE MAIN OBJECTIVE OF THE TRIAL IS TO COMPARE THE EFFICACY OF THE TEST TOPICAL FORMULATION BENZOYL PEROXIDE-ERYTHROMYCIN/VERISFIELD, GEL, (5+3)% TO THE REFERENCE BENZADERMINE/LABORATOIRES PHARMACETIQUES TRENKER, GEL, (5+3)% AND TO EVALUATE THE THERAPEUTIC EQUIVALENCE BETWEEN THE TWO PRODUCTS IN PATIENTS WITH A CLINICAL DIAGNOSIS OF MILD TO MODERATE ACNE VULGARIS;Secondary Objective: EVALUATION OF THE SAFETY;Primary end point(s): FINDINGS THAT DEMONSTRATE THE THERAPEUTIC EQUIVALENCE BETWEEN THE TEST (BENZOYL-PEROXIDE-ERYTHROMYCIN/VERISFIELD) AND THE REFERENCE PRODUCT (BENZADERMINE/LABORATOIRES PHARMACETIQUES TRENKER).