Papulopustular Rosacea (PPR)
Conditions
Brief summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Interventions
DRUGCD5024
CD5024 1% Cream, once daily
Topical Gel applied twice daily
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe), 2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion criteria
1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne, 2. The subject has rosacea with more than two nodules on the face.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | Week 12 | Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema) |
| Absolute Change in Inflammatory Lesion Count | Baseline to Week 12 | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | Baseline to Week 12 | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD5024 1% Cream Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks | 451 |
| CD5024 Vehicle Cream/Azelaic Acid 15% Gel Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks | 232 |
| Total | 683 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Part A Vehicle Control (12 Weeks) | Adverse Event | 7 | 4 |
| Part A Vehicle Control (12 Weeks) | Lack of Efficacy | 0 | 1 |
| Part A Vehicle Control (12 Weeks) | Lost to Follow-up | 7 | 8 |
| Part A Vehicle Control (12 Weeks) | Other (noted on CRF) | 1 | 1 |
| Part A Vehicle Control (12 Weeks) | Pregnancy | 2 | 0 |
| Part A Vehicle Control (12 Weeks) | Protocol Violation | 2 | 1 |
| Part A Vehicle Control (12 Weeks) | Withdrawal by Subject | 18 | 7 |
| Part B Long Term Active Control 40 Weeks | Adverse Event | 5 | 4 |
| Part B Long Term Active Control 40 Weeks | Lack of Efficacy | 2 | 3 |
| Part B Long Term Active Control 40 Weeks | Lost to Follow-up | 16 | 10 |
| Part B Long Term Active Control 40 Weeks | Other (noted on eCRF) | 5 | 1 |
| Part B Long Term Active Control 40 Weeks | Pregnancy | 5 | 1 |
| Part B Long Term Active Control 40 Weeks | Protocol Violation | 1 | 0 |
| Part B Long Term Active Control 40 Weeks | Withdrawal by Subject | 27 | 16 |
| Part C Safety Follow up (4 Weeks) | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | CD5024 1% Cream | CD5024 Vehicle Cream/Azelaic Acid 15% Gel | Total |
|---|---|---|---|
| Age, Continuous | 49.9 Years STANDARD_DEVIATION 12.15 | 51.6 Years STANDARD_DEVIATION 11.92 | 50.4 Years STANDARD_DEVIATION 12.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 23 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 396 Participants | 209 Participants | 605 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 9 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 | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) White | 437 Participants | 220 Participants | 657 Participants |
| Sex: Female, Male Female | 314 Participants | 152 Participants | 466 Participants |
| Sex: Female, Male Male | 137 Participants | 80 Participants | 217 Participants |
| Skin Photo Type I | 39 Participants | 16 Participants | 55 Participants |
| Skin Photo Type II | 185 Participants | 90 Participants | 275 Participants |
| Skin Photo Type III | 167 Participants | 86 Participants | 253 Participants |
| Skin Photo Type IV | 51 Participants | 26 Participants | 77 Participants |
| Skin Photo Type V | 8 Participants | 11 Participants | 19 Participants |
| Skin Photo Type VI | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 452 | 10 / 231 | 93 / 412 | 47 / 210 | 4 / 350 | 0 / 175 | 110 / 452 | 52 / 232 |
| serious Total, serious adverse events | 3 / 452 | 1 / 231 | 7 / 412 | 8 / 210 | 0 / 350 | 1 / 175 | 10 / 452 | 9 / 232 |
Outcome results
Primary
Absolute Change in Inflammatory Lesion Count
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Time frame: Baseline to Week 12
Population: LOCF, ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Absolute Change in Inflammatory Lesion Count | -20.5 Lesion count change | Standard Deviation 15.95 |
| CD5024 Vehicle Cream | Absolute Change in Inflammatory Lesion Count | -12.0 Lesion count change | Standard Deviation 13.55 |
p-value: <0.00195% CI: [-10.12, -6.13]ANCOVA
Primary
Success Rate
Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Time frame: Week 12
Population: LOCF, ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CD5024 1% Cream | Success Rate | 38.4 Percentage of participants |
| CD5024 Vehicle Cream | Success Rate | 11.6 Percentage of participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Time frame: Baseline to Week 12
Population: LOCF, ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | -64.9 Percentage of change in lesion counts | Standard Deviation 39.91 |
| CD5024 Vehicle Cream | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | -41.6 Percentage of change in lesion counts | Standard Deviation 38.83 |
p-value: <0.001Cochran-Mantel-Haenszel