GA YAZ ACNE in China Phase III

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818519
• Other study ID #: 91772
• Secondary ID: 3119632014-00461
• Status: Completed
• Phase: Phase 3
• First received: January 6, 2009
• Last updated: August 12, 2015
• Start date: December 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Food and Drug Administration (SFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• EE20/Drospirenone (YAZ, BAY86-5300)
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
• Placebo
Inert tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	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	No
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)	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No

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