check_circleStudy Completed

Acne Vulgaris

Bayer Identifier:

91772

ClinicalTrials.gov Identifier:

NCT00818519

EudraCT Number:

2014-004612-10

EU CT Number:

Not Available
GA YAZ ACNE in China Phase III

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

14 - 45 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
179
Trial Dates
December 2008 - May 2010
Phase
Phase 3
Could I Receive a placebo
Yes
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
3rd Affiliated Hosp., Sun Yat-sen Univ.Guangzhou, 510630, China
Completed
Changhai Hospital of Second Military Medical UniversityShanghai, 200043, China
Completed
Dermatosis Graduate School of Chinese Academy of Medical ScNanjing, 210042, China
Completed
Peking Union Medical College HospitalBeijing, 100032, China
Completed
Chinese PLA General HospitalBeijing, 100853, China
Completed
2nd Xiangya Hosp., Central South Univ.Changsha, 410011, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China

Primary Outcome

  • 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)
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at screening visit
    date_rangeTime Frame:
    Screening visit
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 1
    date_rangeTime Frame:
    Cycle 1 (Day 15±3 days of Treatment Cycle 1)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 3
    date_rangeTime Frame:
    Cycle 3 (Day 15±3 days of Treatment Cycle 3)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants classified as “0” or “1” on the 6-point ISGA (Investigator Static Global Assessment) scale at Cycle 6
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6)
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in inflammatory lesion count (papules, pustules, and nodules), non-inflammatory lesion count
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in lesion count of papules
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in lesion count of pustules
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in lesion count of nodules
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in lesion count of open comedones
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percent change from Cycle 6 to Baseline in lesion count of closed comedones
    date_rangeTime Frame:
    Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants classified as “improved” according to the Investigator’s Overall Improvement Rating and on the Participant’s Overall Self-Assessment Rating
    date_rangeTime Frame:
    At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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