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 |
|---|---|---|
| Change in Inflammatory Lesion Count From Baseline to Week 12 | 12 weeks | Change from Baseline to Week 12 in Inflammatory Lesion Count |
| Percentage of Participants Who Achieved 2 Grade IGA Reduction. | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. | 6 Weeks | 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). |
| Change in the Number of Inflammatory Lesions From Baseline at Week 9 | 9 weeks | The absolute change in inflammatory lesions from baseline to Week 9 |
| Change in the Number of Inflammatory Lesions From Baseline at Week 6 | 6 weeks | The absolute change in inflammatory lesions from baseline to Week 6 |
| Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. | 9 Weeks | Percentage 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). |
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 Europe from December 2015 to July 2017.
Participants by arm
| Arm | Count |
|---|---|
| Treatment CLS001 (Omiganan) gel applied once daily
CLS001 (Omiganan): Topical gel | 235 |
| Vehicle Gel Vehicle gel applied once daily
Vehicle: Vehicle Gel | 228 |
| Total | 463 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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 | Sponsor Decision | 1 | 0 |
| Double-Blind Study Period | Withdrawal by Subject | 15 | 17 |
| 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 | Terminated by Sponsor | 66 | 69 |
| Open-Label Study Period | Withdrawal by Subject | 33 | 37 |
Baseline characteristics
| Characteristic | Treatment | Total | Vehicle Gel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 67 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 203 Participants | 396 Participants | 193 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 13.06 | 51 years STANDARD_DEVIATION 12.63 | 51.6 years STANDARD_DEVIATION 12.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 80 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 192 Participants | 383 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type I - Always burn, never tan | 29 Participants | 60 Participants | 31 Participants |
| Fitzpatrick Skin Type III - Sometimes mild burn, tans less than average | 79 Participants | 150 Participants | 71 Participants |
| Fitzpatrick Skin Type II - Usually burn, tans less than average (with difficulty) | 97 Participants | 203 Participants | 106 Participants |
| Fitzpatrick Skin Type IV - Rarely burn, tan more than average (with ease) | 28 Participants | 43 Participants | 15 Participants |
| Fitzpatrick Skin Type VI - Never burns, tans profusely | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type V - Rarely burns, tans profusely | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 10 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 222 Participants | 443 Participants | 221 Participants |
| Region of Enrollment Australia | 23 participants | 44 participants | 21 participants |
| Region of Enrollment Canada | 25 participants | 51 participants | 26 participants |
| Region of Enrollment France | 13 participants | 24 participants | 11 participants |
| Region of Enrollment Germany | 66 participants | 134 participants | 68 participants |
| Region of Enrollment Netherlands | 3 participants | 7 participants | 4 participants |
| Region of Enrollment New Zealand | 6 participants | 13 participants | 7 participants |
| Region of Enrollment Sweden | 10 participants | 19 participants | 9 participants |
| Region of Enrollment United Kingdom | 8 participants | 17 participants | 9 participants |
| Region of Enrollment United States | 81 participants | 154 participants | 73 participants |
| Sex: Female, Male Female | 159 Participants | 296 Participants | 137 Participants |
| Sex: Female, Male Male | 76 Participants | 167 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 228 | 0 / 363 |
| other Total, other adverse events | 83 / 235 | 83 / 228 | 116 / 363 |
| serious Total, serious adverse events | 4 / 235 | 4 / 228 | 8 / 363 |
Outcome results
Primary
Change in Inflammatory Lesion Count From Baseline to Week 12
Change from Baseline to Week 12 in Inflammatory Lesion Count
Time frame: 12 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Inflammatory Lesion Count From Baseline to Week 12 | -18.1 Lesions | Standard Error 1.77 |
| Vehicle Gel | Change in Inflammatory Lesion Count From Baseline to Week 12 | -13.5 Lesions | Standard Error 1.85 |
p-value: 0.043ANCOVA
Primary
Percentage of Participants Who Achieved 2 Grade IGA Reduction.
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).
Time frame: 12 weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Participants Who Achieved 2 Grade IGA Reduction. | 26.3 Percentage of Participants |
| Vehicle Gel | Percentage of Participants Who Achieved 2 Grade IGA Reduction. | 16.9 Percentage of Participants |
p-value: 0.019Cochran-Mantel-Haenszel
Secondary
Change in the Number of Inflammatory Lesions From Baseline at Week 6
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 | Change in the Number of Inflammatory Lesions From Baseline at Week 6 | -13.5 Lesions | Standard Error 1.44 |
| Vehicle Gel | Change in the Number of Inflammatory Lesions From Baseline at Week 6 | -11.8 Lesions | Standard Error 1.48 |
Secondary
Change in the Number of Inflammatory Lesions From Baseline at Week 9
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 | Change in the Number of Inflammatory Lesions From Baseline at Week 9 | -17.4 Lesions | Standard Error 1.55 |
| Vehicle Gel | Change in the Number of Inflammatory Lesions From Baseline at Week 9 | -15.2 Lesions | Standard Error 1.6 |
Secondary
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.
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).
Time frame: 6 Weeks
Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. | 13.8 Percentage of Participants |
| Vehicle Gel | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. | 8.9 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
Percentage 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).
Time frame: 9 Weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. | 18.4 Percentage of Participants |
| Vehicle Gel | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. | 14.4 Percentage of Participants |