Acne Vulgaris
Conditions
Keywords
acne
Brief summary
To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.
Interventions
DRUG50 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
DRUGPlacebo
Dose-matched Placebo capsule administered as an oral capsule(s) once daily
DRUG100 mg P005672-HCl
P005672-HCl administered as an oral capsule(s) once daily
Sponsors
Allergan
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* if women of child-bearing potential, have a negative urine pregnancy test * Willing to use only a non-medicated cleanser and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study * Male or female, 12-45 years of age with body weight between 52 and 88 kg * Diagnosis of acne vulgaris with: 20 to 50 inflammatory lesions (papules, pustules, and nodules) 30 to 100 noninflammatory lesions (open and closed comedones) * No more than 2 nodules on the face * Investigator's Global Assessment (IGA) score of moderate (3) to severe (4)
Exclusion criteria
* Dermatological condition of face or facial hair that could interfere with clinical evaluations subjects who have used the following medications (topical refers only to the facial area) will not be eligible: Within 1 week prior to randomization: * Medicated facial cleansers * Topical acne treatments (other than those listed below) Within 4 weeks prior to randomization: * Topical retinoids * Topical anti-inflammatories and corticosteroids * Systemic antibiotics * Systemic acne treatments Within 12 weeks prior to randomization: * Systemic retinoids * Systemic corticosteroids * Pseudomembranous colitis or antibiotic-associated colitis * Hepatitis, liver damage or renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | Baseline (Week 0) to Final Visit (Up to Week 12) | — |
| The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Final Visit (Up to Week 12) | The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Baseline (Week 0) up to Week 12 | — |
| The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Baseline (Week 0) up to Week 12 | — |
| The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Baseline to Final Visit (Up to Week 12) | The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit. |
| The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Baseline (Week 0) up to Week 12 | — |
| The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Baseline (Week 0) up to Week 12 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Two placebo capsules matching P005672-HCl, taken orally each day | 73 |
| P005672-HCl Approximately 0.75 mg/kg/Day One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day | 76 |
| P005672-HCl Approximately 1.5 mg/kg/Day Two P005672-HCl 50 mg capsules, taken orally each day | 70 |
| P005672-HCl Approximately 3.0 mg/kg/Day Two P005672-HCl 100 mg capsules, taken orally each day | 66 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | abnormal laboratory test results | 0 | 0 | 1 | 0 |
| Overall Study | Adverse Event | 1 | 1 | 0 | 4 |
| Overall Study | Lost to Follow-up | 3 | 4 | 3 | 3 |
| Overall Study | positive pregnancy test | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 4 | 1 |
| Overall Study | withdrawn for noncompliance | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | P005672-HCl Approximately 0.75 mg/kg/Day | Total | Placebo | P005672-HCl Approximately 3.0 mg/kg/Day | P005672-HCl Approximately 1.5 mg/kg/Day |
|---|---|---|---|---|---|
| Age, Continuous | 19.7 Years STANDARD_DEVIATION 5.92 | 20.2 Years STANDARD_DEVIATION 6.74 | 20.8 Years STANDARD_DEVIATION 6.99 | 20.3 Years STANDARD_DEVIATION 7.11 | 19.9 Years STANDARD_DEVIATION 7.04 |
| Height | 167.49 cm STANDARD_DEVIATION 9.047 | 166.96 cm STANDARD_DEVIATION 9.206 | 165.80 cm STANDARD_DEVIATION 10.436 | 167.33 cm STANDARD_DEVIATION 9.764 | 167.23 cm STANDARD_DEVIATION 7.38 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 12 Participants | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants | 69 Participants | 17 Participants | 13 Participants | 21 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 21 Participants | 75 Participants | 19 Participants | 19 Participants | 16 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 55 Participants | 210 Participants | 54 Participants | 47 Participants | 54 Participants |
| Race/Ethnicity, Customized White | 55 Participants | 207 Participants | 54 Participants | 52 Participants | 46 Participants |
| Sex/Gender, Customized Female | 47 Participants | 172 Participants | 48 Participants | 37 Participants | 40 Participants |
| Sex/Gender, Customized Male | 29 Participants | 113 Participants | 25 Participants | 29 Participants | 30 Participants |
| Weight at Baseline | 66.37 kg STANDARD_DEVIATION 8.749 | 67.94 kg STANDARD_DEVIATION 10.173 | 68.47 kg STANDARD_DEVIATION 10.306 | 67.31 kg STANDARD_DEVIATION 9.486 | 69.69 kg STANDARD_DEVIATION 11.861 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 73 | 15 / 76 | 8 / 70 | 7 / 66 |
| serious Total, serious adverse events | 0 / 73 | 0 / 76 | 0 / 70 | 0 / 66 |
Outcome results
Primary
The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit
Time frame: Baseline (Week 0) to Final Visit (Up to Week 12)
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | 12.8 Number of Inflammatory Lesions | Standard Deviation 14.18 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | 14.4 Number of Inflammatory Lesions | Standard Deviation 13.01 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | 17.6 Number of Inflammatory Lesions | Standard Deviation 16.65 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | 17.1 Number of Inflammatory Lesions | Standard Deviation 11.69 |
p-value: 0.434495% CI: [-2.32, 5.38]ANCOVA
p-value: 0.026695% CI: [0.52, 8.4]ANCOVA
p-value: 0.031795% CI: [0.39, 8.36]ANCOVA
Primary
The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time frame: Final Visit (Up to Week 12)
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Success | 8 Participants |
| Placebo | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Failure | 64 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Failure | 65 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Success | 11 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Success | 17 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Failure | 53 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Success | 10 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit | Failure | 56 Participants |
p-value: 0.3395% CI: [-7.82, 14.38]Cochran-Mantel-Haenszel
p-value: 0.015995% CI: [0.54, 25.6]Cochran-Mantel-Haenszel
p-value: 0.483495% CI: [-7.44, 15.87]Cochran-Mantel-Haenszel
Secondary
The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 1 | 5.8 Count of Inflammatory Lesions | Standard Deviation 9.07 |
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 2 | 8.4 Count of Inflammatory Lesions | Standard Deviation 10.13 |
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 4 | 10.9 Count of Inflammatory Lesions | Standard Deviation 10.04 |
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 8 | 12.6 Count of Inflammatory Lesions | Standard Deviation 12.57 |
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 12 | 12.8 Count of Inflammatory Lesions | Standard Deviation 14.18 |
| Placebo | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 12.8 Count of Inflammatory Lesions | Standard Deviation 14.18 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 14.4 Count of Inflammatory Lesions | Standard Deviation 13.01 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 8 | 13.1 Count of Inflammatory Lesions | Standard Deviation 11.89 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 1 | 5.4 Count of Inflammatory Lesions | Standard Deviation 9.28 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 4 | 9.3 Count of Inflammatory Lesions | Standard Deviation 13.84 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 2 | 8.5 Count of Inflammatory Lesions | Standard Deviation 10.02 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 12 | 14.3 Count of Inflammatory Lesions | Standard Deviation 13 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 2 | 8.2 Count of Inflammatory Lesions | Standard Deviation 14.45 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 4 | 11.7 Count of Inflammatory Lesions | Standard Deviation 15.36 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 8 | 15.0 Count of Inflammatory Lesions | Standard Deviation 16.66 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 17.6 Count of Inflammatory Lesions | Standard Deviation 16.65 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 12 | 17.6 Count of Inflammatory Lesions | Standard Deviation 16.65 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 1 | 5.4 Count of Inflammatory Lesions | Standard Deviation 8.44 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 12 | 17.1 Count of Inflammatory Lesions | Standard Deviation 11.69 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 17.1 Count of Inflammatory Lesions | Standard Deviation 11.69 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 2 | 9.7 Count of Inflammatory Lesions | Standard Deviation 11.3 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 8 | 14.3 Count of Inflammatory Lesions | Standard Deviation 12.9 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 1 | 5.9 Count of Inflammatory Lesions | Standard Deviation 8.33 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Change from Baseline at Week 4 | 12.8 Count of Inflammatory Lesions | Standard Deviation 9.96 |
Secondary
The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 5.4 Count of Noninflammatory Lesions | Standard Deviation 12.99 |
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 10.6 Count of Noninflammatory Lesions | Standard Deviation 16.02 |
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 13.0 Count of Noninflammatory Lesions | Standard Deviation 24.17 |
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 16.9 Count of Noninflammatory Lesions | Standard Deviation 22.52 |
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 17.8 Count of Noninflammatory Lesions | Standard Deviation 21.63 |
| Placebo | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 17.8 Count of Noninflammatory Lesions | Standard Deviation 21.63 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 17.9 Count of Noninflammatory Lesions | Standard Deviation 19.83 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 14.3 Count of Noninflammatory Lesions | Standard Deviation 21.44 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 3.8 Count of Noninflammatory Lesions | Standard Deviation 14.28 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 10.0 Count of Noninflammatory Lesions | Standard Deviation 17.25 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 9.4 Count of Noninflammatory Lesions | Standard Deviation 13.58 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 17.9 Count of Noninflammatory Lesions | Standard Deviation 19.85 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 7.8 Count of Noninflammatory Lesions | Standard Deviation 16.92 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 9.9 Count of Noninflammatory Lesions | Standard Deviation 20.58 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 14.0 Count of Noninflammatory Lesions | Standard Deviation 22.22 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 19.1 Count of Noninflammatory Lesions | Standard Deviation 22.33 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 19.1 Count of Noninflammatory Lesions | Standard Deviation 22.33 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 4.3 Count of Noninflammatory Lesions | Standard Deviation 14.1 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 17.0 Count of Noninflammatory Lesions | Standard Deviation 21.56 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 17.0 Count of Noninflammatory Lesions | Standard Deviation 21.56 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 7.9 Count of Noninflammatory Lesions | Standard Deviation 14.24 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 15.2 Count of Noninflammatory Lesions | Standard Deviation 19.04 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 5.1 Count of Noninflammatory Lesions | Standard Deviation 13.83 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 12.7 Count of Noninflammatory Lesions | Standard Deviation 15.24 |
Secondary
The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12
The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4. The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit.
Time frame: Baseline to Final Visit (Up to Week 12)
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Failure | 64 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Failure | 64 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Failure | 66 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Success | 0 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Success | 8 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Success | 2 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Failure | 70 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Failure | 72 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Success | 8 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Success | 1 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Failure | 71 Participants |
| Placebo | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Success | 6 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Failure | 73 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Success | 6 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Failure | 73 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Success | 11 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Failure | 65 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Failure | 70 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Success | 3 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Failure | 74 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Success | 2 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Success | 3 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Failure | 65 Participants |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Success | 11 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Failure | 62 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Success | 0 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Failure | 70 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Success | 2 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Failure | 68 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Success | 0 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Failure | 70 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Success | 8 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Success | 17 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Failure | 53 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Success | 17 Participants |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Failure | 53 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Failure | 62 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 4 | Success | 4 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Success | 1 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Failure | 56 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Failure | 64 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 2 | Success | 2 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Failure | 56 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Final Visit (Up to Week 12) | Success | 10 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Failure | 55 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 8 | Success | 11 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 1 | Failure | 65 Participants |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12 | Week 12 | Success | 10 Participants |
Secondary
The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 19.3 Percent Change - Inflammatory Lesions | Standard Deviation 27.82 |
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 25.6 Percent Change - Inflammatory Lesions | Standard Deviation 29.02 |
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 34.1 Percent Change - Inflammatory Lesions | Standard Deviation 28.84 |
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 37.9 Percent Change - Inflammatory Lesions | Standard Deviation 35.6 |
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 39.1 Percent Change - Inflammatory Lesions | Standard Deviation 43 |
| Placebo | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 39.1 Percent Change - Inflammatory Lesions | Standard Deviation 43 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 43.5 Percent Change - Inflammatory Lesions | Standard Deviation 39.72 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 39.8 Percent Change - Inflammatory Lesions | Standard Deviation 34.47 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 17.2 Percent Change - Inflammatory Lesions | Standard Deviation 28.43 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 29.3 Percent Change - Inflammatory Lesions | Standard Deviation 38.9 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 26.4 Percent Change - Inflammatory Lesions | Standard Deviation 32.6 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 43.3 Percent Change - Inflammatory Lesions | Standard Deviation 39.7 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 25.8 Percent Change - Inflammatory Lesions | Standard Deviation 36.16 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 34.1 Percent Change - Inflammatory Lesions | Standard Deviation 35.27 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 44.3 Percent Change - Inflammatory Lesions | Standard Deviation 37.99 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 53.6 Percent Change - Inflammatory Lesions | Standard Deviation 37.65 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 53.6 Percent Change - Inflammatory Lesions | Standard Deviation 37.65 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 17.8 Percent Change - Inflammatory Lesions | Standard Deviation 26.39 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 53.5 Percent Change - Inflammatory Lesions | Standard Deviation 35.18 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 53.5 Percent Change - Inflammatory Lesions | Standard Deviation 35.18 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 30.6 Percent Change - Inflammatory Lesions | Standard Deviation 35.88 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 44.5 Percent Change - Inflammatory Lesions | Standard Deviation 37.62 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 19.4 Percent Change - Inflammatory Lesions | Standard Deviation 26.17 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 40.0 Percent Change - Inflammatory Lesions | Standard Deviation 31.83 |
Secondary
The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit
Time frame: Baseline (Week 0) up to Week 12
Population: Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 35.3 Percent change - noninflammatory lesions | Standard Deviation 35.32 |
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 19.0 Percent change - noninflammatory lesions | Standard Deviation 28.36 |
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 35.3 Percent change - noninflammatory lesions | Standard Deviation 35.32 |
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 25.0 Percent change - noninflammatory lesions | Standard Deviation 37.78 |
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 30.5 Percent change - noninflammatory lesions | Standard Deviation 40.69 |
| Placebo | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 9.7 Percent change - noninflammatory lesions | Standard Deviation 24.07 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 18.3 Percent change - noninflammatory lesions | Standard Deviation 33.17 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 7.7 Percent change - noninflammatory lesions | Standard Deviation 26.87 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 34.3 Percent change - noninflammatory lesions | Standard Deviation 36.4 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 26.1 Percent change - noninflammatory lesions | Standard Deviation 38.84 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 34.1 Percent change - noninflammatory lesions | Standard Deviation 36.28 |
| P005672-HCl Approximately 0.75 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 16.7 Percent change - noninflammatory lesions | Standard Deviation 24.99 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 37.2 Percent change - noninflammatory lesions | Standard Deviation 38.44 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 14.6 Percent change - noninflammatory lesions | Standard Deviation 30.57 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 27.5 Percent change - noninflammatory lesions | Standard Deviation 38.54 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 19.2 Percent change - noninflammatory lesions | Standard Deviation 35.6 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 8.3 Percent change - noninflammatory lesions | Standard Deviation 25.2 |
| P005672-HCl Approximately 1.5 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 37.2 Percent change - noninflammatory lesions | Standard Deviation 38.44 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 4 | 25.7 Percent change - noninflammatory lesions | Standard Deviation 29.27 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 1 | 10.6 Percent change - noninflammatory lesions | Standard Deviation 25.63 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 2 | 16.0 Percent change - noninflammatory lesions | Standard Deviation 30.37 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Final Visit(Up to Week 12) | 32.8 Percent change - noninflammatory lesions | Standard Deviation 42.59 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 8 | 30.4 Percent change - noninflammatory lesions | Standard Deviation 38.45 |
| P005672-HCl Approximately 3.0 mg/kg/Day | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Change from Baseline at Week 12 | 32.8 Percent change - noninflammatory lesions | Standard Deviation 42.59 |