MULTICENTER, RANDOMIZED, DOUBLE-BLIND COMPARATIVE WITH THE REFERENCE PRODUCT CLINICAL STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF THE THERAPY WITH THE COMBINATION ERYTHROMYCIN-ISOTRETINOIN/VERISFIELD, GEL, (2.0+0.05)% W/W FOR THE TOPICAL TREATMENT OF MILD TO MODERATE ACNE
- Conditions
- MILD TO MODERATE ACNE (ACNE VULGARIS)
- Registration Number
- EUCTR2009-016241-25-GR
- Lead Sponsor
- VERISFIELD (UK) LTD, GREEK BRANCH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- PATIENTS WITH MILD TO MODERATE ACNE (ACNE VULGARIS)
- MALE AND FEMALE PATIENTS AGED 12-35 YEARS
- MALES AND FEMALES WHO ARE CONSIDERED HEALTHY
- FEMALE PATIENTS WHO DO NOT MANIFEST ANY SIGNS OF HYPERANDROGENISM
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
- PATIENTS WHO HAVE PARTICIPATED OR CURRENTLY PARTICIPATING IN ANOTHER STUDY
- PATIENTS ON TOPICAL OR SYSTEMIC TREATMENT FOR ACNE
- PATIENTS WHO RECEIVE DRUGS THAT MIGHT INFLUENCE THE FINDINGS OF THE STUDY
- PATIENTS WITH CARDIOVASCULAR, NEOPLASMIC, HAEMATOLOGICAL, HEPATIC, RENAL, NEUROLOGICAL, 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 RECEIVE ADEQUATE CONTRACEPTION
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method