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Completed

NCT Number: NCT00818519

GA YAZ ACNE in China Phase III

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EE20/Drospirenone (YAZ, BAY86-5300)

Drug

20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd

Placebo

Drug

Inert tablet

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2009
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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