Clinical trial NCT00818519: GA YAZ ACNE in China Phase III
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Moderate Acne Vulgaris
Oral contraceptive
Female
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 179
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: 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)
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Secondary outcomes:
measure: Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit
timeFrame: Screening visit
measure: Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1
timeFrame: Cycle 1 (Day 15±3 days of Treatment Cycle 1)
measure: Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3
timeFrame: Cycle 3 (Day 15±3 days of Treatment Cycle 3)
measure: Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6)
measure: Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percent Change From Cycle 6 to Baseline in Lesion Count of Papules
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones
timeFrame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
measure: Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating
timeFrame: At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)
Other outcomes:
Locations:
city: Guangzhou
country: China
state: Guangdong
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: