Trial Outcomes & Findings for GA YAZ ACNE in China Phase III (NCT NCT00818519)
NCT ID: NCT00818519
Last Updated: 2015-08-25
Results Overview
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.
COMPLETED
PHASE3
179 participants
Cycle 6 (Day 15±3 days of Treatment Cycle 6) and Baseline
2015-08-25
Participant Flow
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
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.
Participant milestones
| Measure |
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).
|
Placebo
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
90
|
|
Overall Study
Participants Received Treatment
|
87
|
86
|
|
Overall Study
COMPLETED
|
75
|
71
|
|
Overall Study
NOT COMPLETED
|
14
|
19
|
Reasons for withdrawal
| Measure |
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).
|
Placebo
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
|
Overall Study
participant recovered completely
|
1
|
0
|
|
Overall Study
participant will leave for long tme
|
1
|
0
|
Baseline Characteristics
GA YAZ ACNE in China Phase III
Baseline characteristics by cohort
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=87 Participants
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).
|
Placebo
n=86 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.0 Years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
23.4 Years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
23.7 Years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS
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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=87 Participants
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).
|
Placebo
n=86 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
37.71 Percent change
Standard Deviation 118.73
|
PRIMARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: PPS
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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=74 Participants
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).
|
Placebo
n=69 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
55.56 Percent change
Standard Deviation 32.50
|
SECONDARY outcome
Timeframe: Screening visitPopulation: Full analysis set at screening
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
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=87 Participants
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).
|
Placebo
n=86 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15±3 days of Treatment Cycle 1)Population: FAS, all participants with data for 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
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=84 Participants
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).
|
Placebo
n=84 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 3 (Day 15±3 days of Treatment Cycle 3)Population: FAS, all participants with data for 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
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=81 Participants
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).
|
Placebo
n=81 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
4.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6)Population: FAS, all participants with data for 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
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=73 Participants
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).
|
Placebo
n=71 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
18.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=75 Participants
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).
|
Placebo
n=71 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
60.88 Percent change
Standard Deviation 29.92
|
|
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
|
50.24 Percent change
Standard Deviation 49.93
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=75 Participants
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).
|
Placebo
n=71 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Percent Change From Cycle 6 to Baseline in Lesion Count of Papules
|
72.36 Percent change
Standard Deviation 31.32
|
55.03 Percent change
Standard Deviation 40.19
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=64 Participants
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).
|
Placebo
n=61 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Percent Change From Cycle 6 to Baseline in Lesion Count of Pustules
|
79.88 Percent change
Standard Deviation 40.83
|
78.15 Percent change
Standard Deviation 34.37
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=32 Participants
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).
|
Placebo
n=30 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Percent Change From Cycle 6 to Baseline in Lesion Count of Nodules
|
95.83 Percent change
Standard Deviation 18.45
|
95.00 Percent change
Standard Deviation 20.13
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=72 Participants
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).
|
Placebo
n=69 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Percent Change From Cycle 6 to Baseline in Lesion Count of Open Comedones
|
24.03 Percent change
Standard Deviation 289.46
|
38.31 Percent change
Standard Deviation 94.52
|
SECONDARY outcome
Timeframe: Cycle 6 (Day 15±3 days of Treatment Cycle 6) and BaselinePopulation: FAS (due to missing data number of participants differs from number at 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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=75 Participants
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).
|
Placebo
n=70 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Percent Change From Cycle 6 to Baseline in Lesion Count of Closed Comedones
|
69.52 Percent change
Standard Deviation 42.24
|
48.73 Percent change
Standard Deviation 61.16
|
SECONDARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=79 Participants
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).
|
Placebo
n=73 Participants
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
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
|
78.1 Percentage of participants
|
|
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
|
84.9 Percentage of participants
|
Adverse Events
EE20/Drospirenone (YAZ, BAY86-5300)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EE20/Drospirenone (YAZ, BAY86-5300)
n=87 participants at risk
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).
|
Placebo
n=86 participants at risk
The participants of the placebo group received inert but identical-appearing, color-matched tablets.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.3%
2/87
|
0.00%
0/86
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/87
|
0.00%
0/86
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/87
|
0.00%
0/86
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/87
|
0.00%
0/86
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/87
|
0.00%
0/86
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/87
|
0.00%
0/86
|
|
General disorders
Pyrexia
|
1.1%
1/87
|
0.00%
0/86
|
|
Infections and infestations
Cervicitis
|
1.1%
1/87
|
0.00%
0/86
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
4/87
|
2.3%
2/86
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/87
|
1.2%
1/86
|
|
Infections and infestations
Pneumonia
|
0.00%
0/87
|
1.2%
1/86
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/87
|
1.2%
1/86
|
|
Investigations
Blood cholesterol increased
|
3.4%
3/87
|
1.2%
1/86
|
|
Investigations
Blood potassium decreased
|
0.00%
0/87
|
1.2%
1/86
|
|
Investigations
Blood triglycerides increased
|
1.1%
1/87
|
0.00%
0/86
|
|
Investigations
Glycosylated haemoglobin increased
|
1.1%
1/87
|
0.00%
0/86
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/87
|
2.3%
2/86
|
|
Investigations
White blood cell count decreased
|
0.00%
0/87
|
1.2%
1/86
|
|
Investigations
White blood cells urine positive
|
1.1%
1/87
|
2.3%
2/86
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.1%
1/87
|
0.00%
0/86
|
|
Nervous system disorders
Dizziness
|
0.00%
0/87
|
1.2%
1/86
|
|
Reproductive system and breast disorders
Breast mass
|
2.3%
2/87
|
2.3%
2/86
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
1/87
|
2.3%
2/86
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/87
|
2.3%
2/86
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
1.1%
1/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
1.1%
1/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Menorrhagia
|
8.0%
7/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Menstrual disorder
|
1.1%
1/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/87
|
1.2%
1/86
|
|
Reproductive system and breast disorders
Metrorrhagia
|
8.0%
7/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
1.1%
1/87
|
0.00%
0/86
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.1%
1/87
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/87
|
0.00%
0/86
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/87
|
3.5%
3/86
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60