Acne Vulgaris
Conditions
Keywords
Moderate Acne Vulgaris, Oral contraceptive, Female
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.
Interventions
DRUGEE20/Drospirenone (YAZ, BAY86-5300)
20µg ethinylestradiol, 3mg drospirenone, tablet, orally, opd
DRUGPlacebo
Inert tablet
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 | 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 |
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | 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 |
| Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | 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. |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | 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. |
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | 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 |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | 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. |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones | 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. |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones | 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. |
| Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | 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. |
| Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | 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. |
| Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | 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 |
Countries
China
Participant flow
Recruitment details
Analyzed: 179 participants randomized, 173 in the FAS (Full Analysis Set): 87 in YAZ, 86 in placebo groups, 143 in the PPS (Per Protocol Set): 74 in YAZ, 69 in placebo groups
Pre-assignment details
193 participants screened, 14 failed screening: withdrawal of consent (7), inclusion/exclusion criteria not met (6), participant lost/no further information available (1). study drug intake was unknown (3) and 3 participants to whom study drug was never administered (withdrawal of consent or lost to follow-up) were excluded from FAS.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 87 |
| Placebo The participants of the placebo group received inert but identical-appearing, color-matched tablets. | 86 |
| Total | 173 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | participant recovered completely | 1 | 0 |
| Overall Study | participant will leave for long tme | 1 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 9 |
Baseline characteristics
| Characteristic | Placebo | Total | EE20/Drospirenone (YAZ, BAY86-5300) |
|---|---|---|---|
| Age, Continuous | 23.4 Years STANDARD_DEVIATION 5.4 | 23.7 Years STANDARD_DEVIATION 5.6 | 24.0 Years STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 86 Participants | 173 Participants | 87 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 87 | 19 / 86 |
| serious Total, serious adverse events | 0 / 87 | 0 / 86 |
Outcome results
Primary
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
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | 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) | 66.79 Percent change | Standard Deviation 31.45 |
| Placebo | 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) | 37.71 Percent change | Standard Deviation 118.73 |
Primary
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
Population: PPS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | 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) | 72.63 Percent change | Standard Deviation 27.45 |
| Placebo | 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) | 55.56 Percent change | Standard Deviation 32.5 |
Secondary
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)
Population: FAS, all participants with data for Cycle 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | 1.2 Percentage of participants |
| Placebo | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 1 | 0.0 Percentage of participants |
Secondary
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)
Population: FAS, all participants with data for Cycle 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 | 2.5 Percentage of participants |
| Placebo | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 3 | 4.9 Percentage of participants |
Secondary
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)
Population: FAS, all participants with data for Cycle 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | 49.3 Percentage of participants |
| Placebo | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Cycle 6 | 18.3 Percentage of participants |
Secondary
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
Population: Full analysis set at screening
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Classified as 0 or 1 on the 6-point ISGA (Investigator Static Global Assessment) Scale at Screening Visit | 0.0 Percentage of participants |
Secondary
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)
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | Investigator | 93.7 Percentage of participants |
| EE20/Drospirenone (YAZ, BAY86-5300) | Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | Participant | 94.9 Percentage of participants |
| Placebo | Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | Investigator | 78.1 Percentage of participants |
| Placebo | Percentage of Participants Classified as Improved According to the Investigator's Overall Improvement Rating and on the Participant's Overall Self-Assessment Rating | Participant | 84.9 Percentage of participants |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Inflammatory lesion count | 75.49 Percent change | Standard Deviation 28.11 |
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Non-inflammatory lesion count | 69.27 Percent change | Standard Deviation 33.75 |
| Placebo | Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Inflammatory lesion count | 60.88 Percent change | Standard Deviation 29.92 |
| Placebo | Percent Change From Cycle 6 to Baseline in Inflammatory Lesion Count (Papules, Pustules, and Nodules), Non-inflammatory Lesion Count | Non-inflammatory lesion count | 50.24 Percent change | Standard Deviation 49.93 |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones | 69.52 Percent change | Standard Deviation 42.24 |
| Placebo | Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones | 48.73 Percent change | Standard Deviation 61.16 |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | 95.83 Percent change | Standard Deviation 18.45 |
| Placebo | Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules | 95.00 Percent change | Standard Deviation 20.13 |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones | 24.03 Percent change | Standard Deviation 289.46 |
| Placebo | Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones | 38.31 Percent change | Standard Deviation 94.52 |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | 72.36 Percent change | Standard Deviation 31.32 |
| Placebo | Percent Change From Cycle 6 to Baseline in Lesion Count of Papules | 55.03 Percent change | Standard Deviation 40.19 |
Secondary
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
Population: FAS (due to missing data number of participants differs from number at Baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EE20/Drospirenone (YAZ, BAY86-5300) | Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | 79.88 Percent change | Standard Deviation 40.83 |
| Placebo | Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules | 78.15 Percent change | Standard Deviation 34.37 |