Phase 3
Completed N=179
GA YAZ ACNE in China Phase III
Source: ClinicalTrials.gov NCT00818519 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: 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) — 66.79; 37.71 Percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
66.79; 37.71 | — |
| PRIMARY 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) |
72.63; 55.56 | — |
| SECONDARY Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 |
1.2; 0.0 | — |
| SECONDARY Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 |
2.5; 4.9 | — |
| SECONDARY Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 |
49.3; 18.3 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count |
75.49; 60.88; 69.27; 50.24 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Lesion Count of Papules |
72.36; 55.03 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules |
79.88; 78.15 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules |
95.83; 95.00 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones |
24.03; 38.31 | — |
| SECONDARY Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones |
69.52; 48.73 | — |
| SECONDARY Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating |
93.7; 78.1; 94.9; 84.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00818519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.