GA YAZ ACNE in China Phase III

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: EE20/Drospirenone (YAZ, BAY86-5300)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EE20/Drospirenone (YAZ, BAY86-5300)<br>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). | Drug: EE20/Drospirenone (YAZ, BAY86-5300)<br>* 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd<br>|
| Placebo Comparator: Placebo<br>The participants of the placebo group received inert but identical-appearing, color-matched tablets. | Drug: Placebo<br>* Inert tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline | 
| 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) | 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. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Screening visit | 
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | 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 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Cycle 3 (Day 15±3 days of Treatment Cycle 3) | 
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | ISGA scale 0: Normal, clear skin with no evidence of acne vulgaris; 1: Skin is almost clear: few non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving, not pink-red), no nodular lesions; 2: Few inflammatory lesions, little inflammation, some comedones, no nodular lesions; 3: Non-inflammatory lesions predominate, several inflammatory lesions, one small nodular lesion maybe present; 4: Many inflammatory lesions, up to many comedones, up to a few nodular lesions; 5: Numerous highly inflammatory lesions predominate, many papules and pustules or nodular lesions | Cycle 6 (Day 15±3 days of Treatment Cycle 6) | 
| Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | 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 (lesion count at Baseline - lesion count at Cycle 6)/(lesion count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline | 
| Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | Acne lesions were counted by the trained designee over the entire face. All papules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (papule count at Baseline - papule count at Cycle 6)/(papule count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline | 
| Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | Acne lesions were counted by the trained designee over the entire face. All pustules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (pustule count at Baseline - pustule count at Cycle 6)/(pustule count at Baseline)*100, so that improvement is indicated by a larger percent change. | Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline | 
| Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | Acne lesions were counted by the trained designee over the entire face. All nodules were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (nodule count at Baseline - nodule count at Cycle 6)/(nodule count at Baseline)*100, so that improvement is indicated by a larger percent change. | 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 | Acne lesions were counted by the trained designee over the entire face. All open comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (open comedone count at Baseline -open comedone count at Cycle 6)/(open comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | 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 | Acne lesions were counted by the trained designee over the entire face. All closed comedones were to be identified and separately counted. The percent change from Cycle 6 to Baseline was calculated as (closed comedone count at Baseline - closed comedone count at Cycle 6)/(closed comedone count at Baseline)*100, so that improvement is indicated by a larger percent change. | 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 | The proportion of participants rated as improved comprises those with complete remission, excellent, marked, or moderate improvement according to the Investigator's Overall Improvement Rating and those with excellent, good, or fair improvement the Participant's Overall Self-Assessment Rating. No improvement or deterioration (worsening of disease signs and symptoms compared to Baseline in the view of investigator/subject) comprise not improved status. | At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate Acne Vulgaris, Oral contraceptive, Female