Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle (NCT NCT02576860)
NCT ID: NCT02576860
Last Updated: 2022-08-02
Results Overview
Absolute change in inflammatory lesion count from baseline to Week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
263 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 durope from December 2015 to February 2017.
Participant milestones
| Measure |
Treatment
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
127
|
|
Overall Study
COMPLETED
|
111
|
103
|
|
Overall Study
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
| Measure |
Treatment
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
13
|
8
|
|
Overall Study
Disallowed medication
|
1
|
0
|
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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
Total
n=263 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
|
109 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 13.66 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
228 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
252 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Total Inflammatory Lesion Count
|
53.1 lesion count
STANDARD_DEVIATION 24.78 • n=5 Participants
|
51.0 lesion count
STANDARD_DEVIATION 19.42 • n=7 Participants
|
52.1 lesion count
STANDARD_DEVIATION 22.34 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Absolute change in inflammatory lesion count from baseline to Week 12.
Outcome measures
| Measure |
Treatment
n=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy Absolute Change in Inflammatory Lesion Count
|
-19.8 Lesions
Standard Error 2.29
|
-20.9 Lesions
Standard Error 2.36
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Proportion of Subjects 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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy IGA: 2 Grade Reduction
|
24.6 Percentage of Subjects
|
25.6 Percentage of Subjects
|
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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy The Absolute Change in Inflammatory Lesions
|
-21.6 Lesions
Standard Error 2.23
|
-20.9 Lesions
Standard Error 2.3
|
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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy The Absolute Change in Inflammatory Lesions
|
-16.2 Lesions
Standard Error 1.96
|
-19.8 Lesions
Standard Error 2.06
|
SECONDARY outcome
Timeframe: 9 WeeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Proportion of Subjects 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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy IGA: 2 Point Reduction
|
23.7 Percentage of Subjects
|
21.6 Percentage of Subjects
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Proportion of Subjects 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=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Efficacy IGA: 2 Point Reduction
|
15.2 Percentage of Subjects
|
15.9 Percentage of Subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Outcome measures
| Measure |
Treatment
n=136 Participants
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 Participants
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Safety Adverse Events
|
19 Participants
|
17 Participants
|
Adverse Events
Treatment
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Vehicle Gel
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=136 participants at risk
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 participants at risk
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Infections and infestations
Salmonellosis
|
0.74%
1/136 • Number of events 1 • 115 Days
|
0.00%
0/127 • 115 Days
|
Other adverse events
| Measure |
Treatment
n=136 participants at risk
CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel
|
Vehicle Gel
n=127 participants at risk
Vehicle gel applied once daily
Vehicle: Vehicle gel
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
8/136 • 115 Days
|
5.5%
7/127 • 115 Days
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
5/136 • 115 Days
|
1.6%
2/127 • 115 Days
|
|
Infections and infestations
Bronchitis
|
2.2%
3/136 • 115 Days
|
1.6%
2/127 • 115 Days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/136 • 115 Days
|
3.1%
4/127 • 115 Days
|
|
General disorders
Application site pain
|
6.6%
9/136 • 115 Days
|
1.6%
2/127 • 115 Days
|
|
General disorders
Application site erythema
|
2.9%
4/136 • 115 Days
|
3.9%
5/127 • 115 Days
|
|
General disorders
Application site pruritus
|
2.2%
3/136 • 115 Days
|
3.9%
5/127 • 115 Days
|
|
Nervous system disorders
Headache
|
6.6%
9/136 • 115 Days
|
4.7%
6/127 • 115 Days
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
2.2%
3/136 • 115 Days
|
2.4%
3/127 • 115 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
3/136 • 115 Days
|
0.00%
0/127 • 115 Days
|
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