Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle (NCT NCT02547441)
NCT ID: NCT02547441
Last Updated: 2022-08-02
Results Overview
Change from Baseline to Week 12 in Inflammatory Lesion Count
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-08-02
Participant Flow
The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and Europe from December 2015 to July 2017.
Participant milestones
| Measure |
CLS001 (Omiganan) Gel
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Double-Blind Study Period
STARTED
|
235
|
228
|
|
Double-Blind Study Period
COMPLETED
|
211
|
196
|
|
Double-Blind Study Period
NOT COMPLETED
|
24
|
32
|
|
Open-Label Study Period
STARTED
|
188
|
175
|
|
Open-Label Study Period
COMPLETED
|
66
|
48
|
|
Open-Label Study Period
NOT COMPLETED
|
122
|
127
|
Reasons for withdrawal
| Measure |
CLS001 (Omiganan) Gel
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Double-Blind Study Period
Adverse Event
|
4
|
9
|
|
Double-Blind Study Period
Lost to Follow-up
|
2
|
4
|
|
Double-Blind Study Period
Physician Decision
|
1
|
0
|
|
Double-Blind Study Period
Protocol Violation
|
1
|
2
|
|
Double-Blind Study Period
Withdrawal by Subject
|
15
|
17
|
|
Double-Blind Study Period
Sponsor Decision
|
1
|
0
|
|
Open-Label Study Period
Adverse Event
|
10
|
11
|
|
Open-Label Study Period
Lack of Efficacy
|
3
|
2
|
|
Open-Label Study Period
Lost to Follow-up
|
7
|
8
|
|
Open-Label Study Period
Physician Decision
|
1
|
0
|
|
Open-Label Study Period
Protocol Violation
|
2
|
0
|
|
Open-Label Study Period
Withdrawal by Subject
|
33
|
37
|
|
Open-Label Study Period
Terminated by Sponsor
|
66
|
69
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
Baseline characteristics by cohort
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
203 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
396 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 12.16 • n=7 Participants
|
51 years
STANDARD_DEVIATION 12.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
159 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
222 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=5 Participants
|
73 participants
n=7 Participants
|
154 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
23 participants
n=5 Participants
|
21 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
France
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
66 participants
n=5 Participants
|
68 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I - Always burn, never tan
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II - Usually burn, tans less than average (with difficulty)
|
97 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III - Sometimes mild burn, tans less than average
|
79 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV - Rarely burn, tan more than average (with ease)
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V - Rarely burns, tans profusely
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI - Never burns, tans profusely
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Change from Baseline to Week 12 in Inflammatory Lesion Count
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Change in Inflammatory Lesion Count From Baseline to Week 12
|
-18.1 Lesions
Standard Error 1.77
|
-13.5 Lesions
Standard Error 1.85
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Percentage of participants who achieved 2 grade IGA reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
|
26.3 Percentage of Participants
|
16.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
The absolute change in inflammatory lesions from baseline to Week 9
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Change in the Number of Inflammatory Lesions From Baseline at Week 9
|
-17.4 Lesions
Standard Error 1.55
|
-15.2 Lesions
Standard Error 1.60
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
The absolute change in inflammatory lesions from baseline to Week 6
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Change in the Number of Inflammatory Lesions From Baseline at Week 6
|
-13.5 Lesions
Standard Error 1.44
|
-11.8 Lesions
Standard Error 1.48
|
SECONDARY outcome
Timeframe: 9 WeeksPercentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
|
18.4 Percentage of Participants
|
14.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Outcome measures
| Measure |
Treatment
n=235 Participants
CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=228 Participants
Vehicle gel applied once daily
Vehicle: Vehicle Gel
|
|---|---|---|
|
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
|
13.8 Percentage of Participants
|
8.9 Percentage of Participants
|
Adverse Events
CLS001 (Omiganan) Gel (Double-Blind Period)
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Vehicle Gel (Double-Blind Period)
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
CLS001 (Omiganan) Gel (Open-Label Period)
Serious events: 8 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLS001 (Omiganan) Gel (Double-Blind Period)
n=235 participants at risk
CLS001 (Omiganan) topical gel applied once daily for 12-week
|
Vehicle Gel (Double-Blind Period)
n=228 participants at risk
Vehicle topical gel applied once daily for 12-week
|
CLS001 (Omiganan) Gel (Open-Label Period)
n=363 participants at risk
CLS001 (Omiganan) topical gel applied once daily for maximum 1-year
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.43%
1/235 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Nervous system disorders
Seizures
|
0.43%
1/235 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Cardiac disorders
Coronary artery disease
|
0.43%
1/235 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Chest pain
|
0.43%
1/235 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Nervous system disorders
Presyncope
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.44%
1/228 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.44%
1/228 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.44%
1/228 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.44%
1/228 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/363 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Injury, poisoning and procedural complications
Achilles tendon rupture left
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell non hodgkin lymphoma
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Infections and infestations
Acute cellulitis
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma in situ of the lentigo maligna type, level 1
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Musculoskeletal and connective tissue disorders
Herniated vertebral disc (cervical spine)
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Musculoskeletal and connective tissue disorders
Primary gonarthrosis left
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal carcinoma
|
0.00%
0/235 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.00%
0/228 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
Other adverse events
| Measure |
CLS001 (Omiganan) Gel (Double-Blind Period)
n=235 participants at risk
CLS001 (Omiganan) topical gel applied once daily for 12-week
|
Vehicle Gel (Double-Blind Period)
n=228 participants at risk
Vehicle topical gel applied once daily for 12-week
|
CLS001 (Omiganan) Gel (Open-Label Period)
n=363 participants at risk
CLS001 (Omiganan) topical gel applied once daily for maximum 1-year
|
|---|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.7%
18/235 • Number of events 18 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
9.6%
22/228 • Number of events 23 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
11.3%
41/363 • Number of events 57 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
14/235 • Number of events 17 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
1.8%
4/228 • Number of events 4 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
3.6%
13/363 • Number of events 15 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Application site dermatitis
|
2.1%
5/235 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.44%
1/228 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
1.4%
5/363 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Application site pain
|
2.1%
5/235 • Number of events 7 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
3.5%
8/228 • Number of events 9 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
1.7%
6/363 • Number of events 6 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Application site pruritus
|
2.1%
5/235 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.88%
2/228 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.55%
2/363 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Application site erythema
|
1.7%
4/235 • Number of events 4 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
3.1%
7/228 • Number of events 8 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
1.4%
5/363 • Number of events 6 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
General disorders
Application site dryness
|
0.85%
2/235 • Number of events 3 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
2.2%
5/228 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
1.4%
5/363 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Nervous system disorders
Headache
|
7.7%
18/235 • Number of events 24 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
6.1%
14/228 • Number of events 24 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
5.2%
19/363 • Number of events 27 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Gastrointestinal disorders
Nausea
|
2.1%
5/235 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.88%
2/228 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.28%
1/363 • Number of events 1 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
3/235 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
2.2%
5/228 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.83%
3/363 • Number of events 3 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.85%
2/235 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
2.2%
5/228 • Number of events 5 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
0.55%
2/363 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.85%
2/235 • Number of events 2 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
3.5%
8/228 • Number of events 8 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
3.9%
14/363 • Number of events 17 • 12-week in Double-Blind Period and maximum 1 year in Open-Label Period
|
Additional Information
Maruho Co., Ltd. Kyoto R&D Center
Clinical Development Dept.
Phone: +81-75-325-3255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place