A Multicenter, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of an Oral Contraceptive Preparation YAZ (Drospirenone 3 mg / Ethinylestradiol 20 µg) for 6 Treatment Cycles in Women With Moderate Acne
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 179
- Primary Endpoint
- Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of YAZ (drospirenone 3 mg / ethinylestradiol 20 µg) in comparison with placebo in female patients with moderate acne vulgaris over 6 treatment cycles.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
EE20/Drospirenone (YAZ, BAY86-5300)
In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
Intervention: EE20/Drospirenone (YAZ, BAY86-5300) (Drug)
Placebo
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the FAS (Full Analysis Set)
Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
Percent Change From Cycle 6 to Baseline in the Total Lesion Count (Open and Closed Comedones, Papules, Pustules, and Nodules) in the PPS (Per Protocol Set)
Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Acne lesions were counted by the trained designee over the entire face. All types of lesions were to be identified and separately counted, i.e., non-inflammatory open and closed comedones, and inflammatory papules, pustules, and nodules. The percent change from Cycle 6 to Baseline was calculated as (total lesion count at Baseline - total lesion count at Cycle 6)/(total lesion count at Baseline)\*100, so that improvement is indicated by a larger percent change.
Secondary Outcomes
- Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit(Screening visit)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1(Cycle 1 (Day 15±3 days of Treatment Cycle 1))
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3(Cycle 3 (Day 15±3 days of Treatment Cycle 3))
- Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6(Cycle 6 (Day 15±3 days of Treatment Cycle 6))
- Percent Change From Cycle 6 to Baseline in Lesion Count of Papules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones(Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline)
- Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating(At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle))