Acne Vulgaris
Conditions
Brief summary
The study hypothesis are based on the assumption that : * CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects * CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile
Interventions
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, who is 12 years of age or older at Screening visit. 2. Clinical diagnosis of acne vulgaris with facial involvement. 3. An IGA of Moderate (3) or Severe (4) at Baseline visit. 4. A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit. 5. A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.
Exclusion criteria
1. More than 2 acne nodules on the face at Baseline visit. 2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. 3. Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial. 4. The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit 5. The subject is unwilling to refrain from use of prohibited medication during the clinical trial. 6. Use of hormonal contraceptives solely for control of acne.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate | Week 12 | Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets. |
| Changes From Baseline in Inflammatory Lesion Counts | Baseline - Week12 | — |
| Changes From Baseline in Non-Inflammatory Lesion Counts | Baseline - Week 12 | — |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CD0271 0.3% /CD1579 2.5% Gel Active arm
CD0271 0.3% / CD1579 2.5% | 217 |
| CD0271 0.1% / CD1579 2.5% Comparator arm
CD0271 0.1% / CD1579 2.5% | 217 |
| Topical Gel Vehicle Placebo arm
Topical Gel Vehicle | 69 |
| Total | 503 |
Baseline characteristics
| Characteristic | CD0271 0.3% /CD1579 2.5% Gel | CD0271 0.1% / CD1579 2.5% | Topical Gel Vehicle | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 124 Participants | 136 Participants | 43 Participants | 303 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 93 Participants | 81 Participants | 26 Participants | 200 Participants |
| Age, Continuous | 20.1 years STANDARD_DEVIATION 7.59 | 19.4 years STANDARD_DEVIATION 6.75 | 18.5 years STANDARD_DEVIATION 5.72 | 19.6 years STANDARD_DEVIATION 7.01 |
| Baseline Investigator Global Assessment (IGA) Baseline IGA = Moderate (3) | 111 participants | 105 participants | 35 participants | 251 participants |
| Baseline Investigator Global Assessment (IGA) Baseline IGA = Severe (4) | 106 participants | 112 participants | 34 participants | 252 participants |
| Region of Enrollment Canada | 17 participants | 16 participants | 5 participants | 38 participants |
| Region of Enrollment United States | 200 participants | 201 participants | 64 participants | 465 participants |
| Sex: Female, Male Female | 113 Participants | 114 Participants | 36 Participants | 263 Participants |
| Sex: Female, Male Male | 104 Participants | 103 Participants | 33 Participants | 240 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 34 / 217 | 23 / 217 | 13 / 69 |
| serious Total, serious adverse events | 0 / 217 | 1 / 217 | 0 / 69 |
Outcome results
Primary
Changes From Baseline in Inflammatory Lesion Counts
Time frame: Baseline - Week12
Population: ITT Population, Multiple imputation
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CD0271 0.3% /CD1579 2.5% Gel | Changes From Baseline in Inflammatory Lesion Counts | All Subjects | -27.04 Lesions | Standard Error 0.846 |
| CD0271 0.3% /CD1579 2.5% Gel | Changes From Baseline in Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -35.17 Lesions | Standard Error 1.407 |
| CD0271 0.1% / CD1579 2.5% | Changes From Baseline in Inflammatory Lesion Counts | All Subjects | -26.72 Lesions | Standard Error 0.822 |
| CD0271 0.1% / CD1579 2.5% | Changes From Baseline in Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -31.92 Lesions | Standard Error 1.32 |
| Topical Gel Vehicle | Changes From Baseline in Inflammatory Lesion Counts | All Subjects | -14.40 Lesions | Standard Error 1.46 |
| Topical Gel Vehicle | Changes From Baseline in Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -15.46 Lesions | Standard Error 2.297 |
Primary
Changes From Baseline in Non-Inflammatory Lesion Counts
Time frame: Baseline - Week 12
Population: ITT Population, Multiple Imputation
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CD0271 0.3% /CD1579 2.5% Gel | Changes From Baseline in Non-Inflammatory Lesion Counts | All Subjects | -40.18 lesions | Standard Error 1.332 |
| CD0271 0.3% /CD1579 2.5% Gel | Changes From Baseline in Non-Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -45.61 lesions | Standard Error 2.058 |
| CD0271 0.1% / CD1579 2.5% | Changes From Baseline in Non-Inflammatory Lesion Counts | All Subjects | -39.00 lesions | Standard Error 1.277 |
| CD0271 0.1% / CD1579 2.5% | Changes From Baseline in Non-Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -43.10 lesions | Standard Error 1.847 |
| Topical Gel Vehicle | Changes From Baseline in Non-Inflammatory Lesion Counts | All Subjects | -18.47 lesions | Standard Error 2.27 |
| Topical Gel Vehicle | Changes From Baseline in Non-Inflammatory Lesion Counts | Baseline IGA = Severe (4) | -17.25 lesions | Standard Error 3.337 |
Primary
Success Rate
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Time frame: Week 12
Population: Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CD0271 0.3% /CD1579 2.5% Gel | Success Rate | All subjects (MI: Multiple Imputation) | 33.7 percentage of participants |
| CD0271 0.3% /CD1579 2.5% Gel | Success Rate | Baseline IGA=Severe (4) (MI: Multiple Imputation) | 31.9 percentage of participants |
| CD0271 0.1% / CD1579 2.5% | Success Rate | All subjects (MI: Multiple Imputation) | 27.3 percentage of participants |
| CD0271 0.1% / CD1579 2.5% | Success Rate | Baseline IGA=Severe (4) (MI: Multiple Imputation) | 20.5 percentage of participants |
| Topical Gel Vehicle | Success Rate | All subjects (MI: Multiple Imputation) | 11.0 percentage of participants |
| Topical Gel Vehicle | Success Rate | Baseline IGA=Severe (4) (MI: Multiple Imputation) | 11.8 percentage of participants |