GA YAZ ACNE in China Phase III - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00818519

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 III

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:

MedlinePlus related topics: Acne

Drug Information available for: Estradiol Ethinyl estradiol 1,2-Dihydrospirorenone

U.S. FDA Resources

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma 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 10, 2011
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 February 09, 2012