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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
179
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
Inert tablet
Unnamed facility
Guangzhou, Guangdong, China
Unnamed facility
Changsha, Hunan, China
Unnamed facility
Nanjing, Jiangsu, China
Unnamed facility
Chengdu, Sichuan, China
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)
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
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)
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at 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
Time frame: Screening visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Shanghai, China
Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at 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
Time frame: Cycle 1 (Day 15±3 days of Treatment Cycle 1)
Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at 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
Time frame: Cycle 3 (Day 15±3 days of Treatment Cycle 3)
Percentage of Participants Classified as "0" or "1" on the 6-point ISGA (Investigator Static Global Assessment) Scale at 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
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6)
Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percent Change From Cycle 6 to Baseline in Lesion Count of Papules
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones
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.
Time frame: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
Percentage of Participants Classified as "Improved" According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating
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.
Time frame: At Cycle 6 (Day 15±3 days of Treatment Cycle 6, 28 days per cycle)