GA YAZ ACNE in China Phase III

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: EE20/Drospirenone (YAZ, BAY86-5300); Drug: Placebo

• Registration Number: NCT00818519
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-06
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-04-06
• Results First Submitted QC: 2011-05-10
• Results First Posted: 2011-06-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 179

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EE20/Drospirenone (YAZ, BAY86-5300)	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).
Placebo	Placebo	The participants of the placebo group received inert but identical-appearing, color-matched tablets.

Primary Outcome Measures

Name	Time	Method
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)	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)	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 Outcome Measures

Name	Time	Method
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	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.
Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit	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
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)	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
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)	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
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)	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
Percent Change From Cycle 6 to Baseline in Lesion Count of Papules	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 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.
Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules	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 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.
Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules	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 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.
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	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.
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	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.
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)	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.