GA YAZ ACNE in China Phase III

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00818519
First received: January 6, 2009
Last updated: May 22, 2014
Last verified: May 2014

January 6, 2009
May 22, 2014
December 2008
May 2010   (final data collection date for primary outcome 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) [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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) [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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.
The primary efficacy variable is the percent change from baseline to Cycle 6 in total lesion count. [ Time Frame: 6 cycles (1 cycle= 28 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00818519 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit [ Time Frame: Screening visit ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 1 (Day 15±3 days of Treatment Cycle 1) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 3 (Day 15±3 days of Treatment Cycle 3) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) ] [ Designated as safety issue: No ]
    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 Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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.
  • Percent Change From Cycle 6 to Baseline in Lesion Count of Papules [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle) ] [ Designated as safety issue: No ]
    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.
  • Percentage of patients classified as '0' or '1' on the 6-point Investigator Static Global Assessment scale [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
  • Percent change from baseline in inflammatory lesion counts, non-inflammatory lesion counts [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
  • Percent change from baseline in papules, pustules, nodules, open comedones, and closed comedones [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
  • Percentage of patients showing improvement on the Investigator's Overall Improvement Rating and Subject's Overall Self-Assessment Rating [ Time Frame: 6 cycles ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Whole study period ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
GA YAZ ACNE in China Phase III
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Acne Vulgaris
  • Drug: EE20/Drospirenone (YAZ, BAY86-5300)
    20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
  • Drug: Placebo
    Inert tablet
  • Experimental: 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).
    Intervention: Drug: EE20/Drospirenone (YAZ, BAY86-5300)
  • Placebo Comparator: Placebo
    The participants of the placebo group received inert but identical-appearing, color-matched tablets.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
14 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00818519
91772, 311963
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP