YAZ Acne in China
- Conditions
- Acne VulgarisMedDRA version: 17.1Level: LLTClassification code 10000519Term: Acne vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-004612-10-Outside-EU/EEA
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Female
- Target Recruitment
- 172
Inclusion Criteria: - Women of age 14-45 years - >1 year post-menarche with moderate acne vulgaris who have no known contraindications to combined oral contraceptives - Otherwise healthy, except for the presence of moderate acne - Smokers up to a maximum age of 30 (inclusive) at inclusion
Are the trial subjects under 18? yes
Number of subjects for this age range: 172
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria: - Pregnancy, lactation (less than three menstrual cycles since delivery, abortion, or lactation before start of treatment) - Obesity (Body Mass Index > 30 kg/m2) - Hypersensitivity to any ingredient of the study drug - Any disease or condition that may worsen under hormonal treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives of this study are<br>to demonstrate that the therapeutic efficacy of YAZ is superior to placebo in treating Chinese women with moderate acne vulgaris over 6 treatment cycles and<br>to evaluate the safety profile of YAZ in comparison to placebo in treating Chinese women with moderate acne vulgaris over 6 treatment cycles.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy variable is the percent change from baseline to Cycle 6 in total lesion count.;Timepoint(s) of evaluation of this end point: 6 cycles (1 cycle= 28 days)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Percentage of patients classified as 0” or 1” on the 6-point Investigator Static Global Assessment scale<br>2. Percent change from baseline in inflammatory lesion counts, non-inflammatory lesion counts<br>3. Percent change from baseline in papules, pustules, nodules, open comedones, and closed comedones<br>4. Percentage of patients showing improvement on the Investigator’s Over¬all Improvement Rating and Subject’s Overall Self-Assessment Rating<br>5. Adverse events <br>6. Laboratory tests;Timepoint(s) of evaluation of this end point: 6 cycles/Whole study period