MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE STUDY WITH THE REFERENCE PRODUCTS, FOR ASSESSMENT OF THERAPEUTIC SUPERIORITY OF THE COMBINATION CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)%, (VERSUS THE MONOTHERAPY WITH CLINDAMYCIN OR TRETINOIN) FOR THE TOPICAL TREATMENT OF ACNE

• Conditions: ACNE (ACNE VULGARIS)

• Registration Number: EUCTR2009-017201-11-GR
• Lead Sponsor: VERISFIELD (UK) LTD, GREEK BRANCH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-19
• 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
- PATIENTS WHO ACCORDING TO THE MEDICAL SUPERVISOR ARE HEALTHY
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 OF GASTROENTEROLOGICAL DISEASE
- PATIENTS WITH A DERMATOLOGICAL LESION IN THE AREA (OR IN CLOSE PROXIMITY e.g. 3cm) TO BE TREATED
- PREGNANT OF LACTATING PATIENTS
- 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: MAIN OBJECTIVE OF THE CLINICAL STUDY IS THE ASSESSMENT OF THERAPEUTIC SUPERIORITY OF THE COMBINATION CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)% FOR THE TOPICAL TREATMENT OF ACNE, VERSUS THE MONOTHERAPY WITH CLINDAMYCIN, GEL, 1.0% AND TRETINOIN, GEL, 0.025%, SEPARATELY FOR THE TOPICAL TREATMENT OF ACNE;Secondary Objective: ASSESSMENT OF SAFETY OF THE TOPICAL TREATMENT WITH COMBINATION OF CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)%;Primary end point(s): FINDINGS THAT DEMONSTRATE THE THERAPEUTIC SUPERIORITY OF THE COMBINATION OF CLINDAMYCIN-TRETINOIN/VERISFIELD, GEL, (1.0+0.025)% COMPARED TO THE MONOTHERPAPIES WITH DALACIN-C, GEL, 1.0% AND RETIN-A, GEL, 0.025%