GA YAZ ACNE in China Phase III

• 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: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: EE20/Drospirenone (YAZ, BAY86-5300); Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 179 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: December 2008
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
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).	Drug: EE20/Drospirenone (YAZ, BAY86-5300); 20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Placebo Comparator: Placebo; The participants of the placebo group received inert but identical-appearing, color-matched tablets.	Drug: Placebo; Inert tablet

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Guangdong

Guangzhou, Guangdong, China, 510630

China, Hunan

Changsha, Hunan, China, 410011

China, Jiangsu

Nanjing, Jiangsu, China, 210042

China, Sichuan

Chengdu, Sichuan, China, 610041

China

Beijing, China, 100032

Beijing, China, 100853

Shanghai, China, 200043

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00818519
• Other Study ID Numbers: 91772; 311963 ( Other Identifier: Company internal ); 2014-004612-10 ( EudraCT Number )
• First Posted: January 7, 2009
• Results First Posted: June 9, 2011
• Last Update Posted: August 25, 2015
• Last Verified: August 2015

Keywords provided by Bayer:

Moderate Acne Vulgaris; Oral contraceptive; Female

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Drospirenone; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents