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Trial record 10 of 235 for:    acne AND Percent

GA YAZ ACNE in China Phase III

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ClinicalTrials.gov Identifier: NCT00818519
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : June 9, 2011
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE January 6, 2009
First Posted Date  ICMJE January 7, 2009
Results First Submitted Date  ICMJE April 6, 2011
Results First Posted Date  ICMJE June 9, 2011
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • 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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
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) ]
Change History Complete list of historical versions of study NCT00818519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2013)
  • 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 ]
    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) ]
    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) ]
    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) ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2009)
  • Percentage of patients classified as '0' or '1' on the 6-point Investigator Static Global Assessment scale [ Time Frame: 6 cycles ]
  • Percent change from baseline in inflammatory lesion counts, non-inflammatory lesion counts [ Time Frame: 6 cycles ]
  • Percent change from baseline in papules, pustules, nodules, open comedones, and closed comedones [ Time Frame: 6 cycles ]
  • Percentage of patients showing improvement on the Investigator's Overall Improvement Rating and Subject's Overall Self-Assessment Rating [ Time Frame: 6 cycles ]
  • Adverse events [ Time Frame: Whole study period ]
  • Laboratory tests [ Time Frame: Whole study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GA YAZ ACNE in China Phase III
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: EE20/Drospirenone (YAZ, BAY86-5300)
    20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
  • Drug: Placebo
    Inert tablet
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2011)
179
Original Estimated Enrollment  ICMJE
 (submitted: January 6, 2009)
172
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00818519
Other Study ID Numbers  ICMJE 91772
311963 ( Other Identifier: Company internal )
2014-004612-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date August 2015

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