Rosacea
Conditions
Brief summary
This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.
Interventions
Topical gel
DRUGVehicle
Vehicle gel
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, male and non-pregnant female subjects, 18 years of age or older. 2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline. 3. Subjects with the presence of telangiectasia at Baseline. 4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline. 5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.
Exclusion criteria
1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea). 2. Subjects with nodular rosacea. 3. Standard
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Absolute Change in Inflammatory Lesion Count | 12 weeks | Absolute change in inflammatory lesion count from baseline to Week 12. |
| Efficacy IGA: 2 Grade Reduction | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy The Absolute Change in Inflammatory Lesions | 9 weeks | The absolute change in inflammatory lesions from baseline to Week 9. |
| Efficacy IGA: 2 Point Reduction | 9 Weeks | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Adverse Events | 12 weeks | Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events |
Countries
Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and durope from December 2015 to February 2017.
Participants by arm
| Arm | Count |
|---|---|
| Treatment CLS001 (Omignan) gel applied once daily
CLS001 (Omiganan): Topical gel | 136 |
| Vehicle Gel Vehicle gel applied once daily
Vehicle: Vehicle gel | 127 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Disallowed medication | 1 | 0 |
| 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 |
Baseline characteristics
| Characteristic | Treatment | Vehicle Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 27 Participants | 54 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 100 Participants | 209 Participants |
| Age, Continuous | 51.2 years STANDARD_DEVIATION 14.06 | 52.4 years STANDARD_DEVIATION 13.66 | 51.8 years STANDARD_DEVIATION 13.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 17 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 110 Participants | 228 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 130 Participants | 122 Participants | 252 Participants |
| Region of Enrollment United States | 65 Participants | 64 Participants | 129 Participants |
| Sex: Female, Male Female | 85 Participants | 70 Participants | 155 Participants |
| Sex: Female, Male Male | 51 Participants | 57 Participants | 108 Participants |
| Total Inflammatory Lesion Count | 53.1 lesion count STANDARD_DEVIATION 24.78 | 51.0 lesion count STANDARD_DEVIATION 19.42 | 52.1 lesion count STANDARD_DEVIATION 22.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 127 |
| other Total, other adverse events | 47 / 136 | 36 / 127 |
| serious Total, serious adverse events | 1 / 136 | 0 / 127 |
Outcome results
Primary
Efficacy Absolute Change in Inflammatory Lesion Count
Absolute change in inflammatory lesion count from baseline to Week 12.
Time frame: 12 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy Absolute Change in Inflammatory Lesion Count | -19.8 Lesions | Standard Error 2.29 |
| Vehicle Gel | Efficacy Absolute Change in Inflammatory Lesion Count | -20.9 Lesions | Standard Error 2.36 |
p-value: 0.799ANCOVA
Primary
Efficacy IGA: 2 Grade Reduction
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).
Time frame: 12 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Efficacy IGA: 2 Grade Reduction | 24.6 Percentage of Subjects |
| Vehicle Gel | Efficacy IGA: 2 Grade Reduction | 25.6 Percentage of Subjects |
p-value: 0.858Cochran-Mantel-Haenszel
Secondary
Efficacy IGA: 2 Point Reduction
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).
Time frame: 9 Weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Efficacy IGA: 2 Point Reduction | 23.7 Percentage of Subjects |
| Vehicle Gel | Efficacy IGA: 2 Point Reduction | 21.6 Percentage of Subjects |
Secondary
Efficacy IGA: 2 Point Reduction
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).
Time frame: 6 Weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Efficacy IGA: 2 Point Reduction | 15.2 Percentage of Subjects |
| Vehicle Gel | Efficacy IGA: 2 Point Reduction | 15.9 Percentage of Subjects |
Secondary
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 9.
Time frame: 9 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy The Absolute Change in Inflammatory Lesions | -21.6 Lesions | Standard Error 2.23 |
| Vehicle Gel | Efficacy The Absolute Change in Inflammatory Lesions | -20.9 Lesions | Standard Error 2.3 |
Secondary
Efficacy The Absolute Change in Inflammatory Lesions
The absolute change in inflammatory lesions from baseline to Week 6.
Time frame: 6 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Efficacy The Absolute Change in Inflammatory Lesions | -16.2 Lesions | Standard Error 1.96 |
| Vehicle Gel | Efficacy The Absolute Change in Inflammatory Lesions | -19.8 Lesions | Standard Error 2.06 |
Other Pre-specified
Safety Adverse Events
Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time frame: 12 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Safety Adverse Events | 19 Participants |
| Vehicle Gel | Safety Adverse Events | 17 Participants |