GA YAZ ACNE in China Phase III
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00818519
First received: January 6, 2009
Last updated: May 31, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: EE20/Drospirenone (YAZ, BAY86-5300) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 - pustiule 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.
| Enrollment: | 179 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 14 Years to 45 Years |
| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818519
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:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00818519 History of Changes |
| Other Study ID Numbers: | 91772, 311963 |
| Study First Received: | January 6, 2009 |
| Results First Received: | April 6, 2011 |
| Last Updated: | May 31, 2012 |
| Health Authority: | China: State Food and Drug Administration (SFDA) |
Keywords provided by Bayer:
|
Moderate Acne Vulgaris Oral contraceptive Female |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Ethinyl Estradiol Drospirenone Drospirenone and ethinyl estradiol combination |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Aldosterone Antagonists Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013