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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P005672-HCl approximately 0.75 mg/kg/day | Experimental | One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks |
|
| P005672-HCl approximately 1.5 mg/kg/day | Experimental | Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks |
|
| P005672-HCl approximately 3.0 mg/kg/day | Experimental | Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 mg P005672-HCl | Drug | P005672-HCl administered as an oral capsule(s) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Final Visit (Up to Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit |
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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:
Within 1 week prior to randomization:
Within 4 weeks prior to randomization:
Within 12 weeks prior to randomization:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Warner Chilcott Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Two placebo capsules matching P005672-HCl, taken orally each day |
| FG001 | P005672-HCl Approximately 0.75 mg/kg/Day | One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Dose-matched Placebo capsule administered as an oral capsule(s) once daily |
|
|
| 100 mg P005672-HCl | Drug | P005672-HCl administered as an oral capsule(s) once daily |
|
|
| Baseline (Week 0) up to Week 12 |
| 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 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 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. | Baseline to Final Visit (Up to Week 12) |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Warner Chilcott Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| Warner Chilcott Investigational Site | Los Angeles | California | 90045 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92123 | United States |
| Warner Chilcott Investigational Site | Santa Monica | California | 90404 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33761 | United States |
| Warner Chilcott Investigational Site | Coral Gables | Florida | 33134 | United States |
| Warner Chilcott Investigational Site | Gainesville | Florida | 32605 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33175 | United States |
| Warner Chilcott Investigational Site | Miramar | Florida | 33027 | United States |
| Warner Chilcott Investigational Site | Pinellas Park | Florida | 33781 | United States |
| Warner Chilcott Investigational Site | Arlington Heights | Illinois | 60005 | United States |
| Warner Chilcott Investigational Site | Chicago | Illinois | 60611 | United States |
| Warner Chilcott Investigational Site | Granger | Indiana | 46530 | United States |
| Warner Chilcott Investigational Site | Indianapolis | Indiana | 46256 | United States |
| Warner Chilcott Investigational Site | Louisville | Kentucky | 40202 | United States |
| Warner Chilcott Investigational Site | Boston | Massachusetts | 02135 | United States |
| Warner Chilcott Investigational Site | Fridley | Minnesota | 44532 | United States |
| Warner Chilcott Investigational Site | St Louis | Missouri | 63117 | United States |
| Warner Chilcott Investigational Site | Berlin | New Jersey | 08009 | United States |
| Warner Chilcott Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14609 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14623 | United States |
| Warner Chilcott Investigational Site | Charlotte | North Carolina | 28209 | United States |
| Warner Chilcott Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Warner Chilcott Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Warner Chilcott Investigational Site | Cincinnati | Ohio | 45249 | United States |
| Warner Chilcott Investigational Site | Portland | Oregon | 97210 | United States |
| Warner Chilcott Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Warner Chilcott Investigational Site | Greer | South Carolina | 29650 | United States |
| Warner Chilcott Investigational Site | Arlington | Texas | 76011 | United States |
| Warner Chilcott Investigational Site | Austin | Texas | 78759 | United States |
| Warner Chilcott Investigational Site | Houston | Texas | 77065 | United States |
| Warner Chilcott Investigational Site | Plano | Texas | 75093 | United States |
| Warner Chilcott Investigational Site | San Antonio | Texas | 78229 | United States |
| Warner Chilcott Investigational Site | Sandy City | Utah | 84070 | United States |
| Warner Chilcott Investigational Site | Lynchburg | Virginia | 24501 | United States |
| FG002 | P005672-HCl Approximately 1.5 mg/kg/Day | Two P005672-HCl 50 mg capsules, taken orally each day |
| FG003 | P005672-HCl Approximately 3.0 mg/kg/Day | Two P005672-HCl 100 mg capsules, taken orally each day |
| COMPLETED |
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| NOT COMPLETED |
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|
285 participants were randomized to double-blind treatment (Safety population)
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Two placebo capsules matching P005672-HCl, taken orally each day |
| BG001 | P005672-HCl Approximately 0.75 mg/kg/Day | One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day |
| BG002 | P005672-HCl Approximately 1.5 mg/kg/Day | Two P005672-HCl 50 mg capsules, taken orally each day |
| BG003 | P005672-HCl Approximately 3.0 mg/kg/Day | Two P005672-HCl 100 mg capsules, taken orally each day |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Five subjects in the Safety Population checked multiple races. | Number | Participants |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight at Baseline | Mean | Standard Deviation | kg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population. | Posted | Mean | Standard Deviation | Number of Inflammatory Lesions | Baseline (Week 0) to Final Visit (Up to Week 12) |
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| 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. | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Count of Participants | Participants | Final Visit (Up to Week 12) |
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| Secondary | The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Mean | Standard Deviation | Count of Inflammatory Lesions | Baseline (Week 0) up to Week 12 |
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| Secondary | The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Mean | Standard Deviation | Count of Noninflammatory Lesions | Baseline (Week 0) up to Week 12 |
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| Secondary | The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Mean | Standard Deviation | Percent Change - Inflammatory Lesions | Baseline (Week 0) up to Week 12 |
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| Secondary | The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Mean | Standard Deviation | Percent change - noninflammatory lesions | Baseline (Week 0) up to Week 12 |
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| 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. | Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population | Posted | Count of Participants | Participants | Baseline to Final Visit (Up to Week 12) |
|
From Screening (up to week -12) to Week 12 plus 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Two placebo capsules matching P005672-HCl, taken orally each day | 0 | 73 | 13 | 73 | ||
| EG001 | P005672-HCl Approximately 0.75 mg/kg/Day | One P005672-HCl 50 mg capsule and one Placebo capsule, taken orally each day | 0 | 76 | 15 | 76 | ||
| EG002 | P005672-HCl Approximately 1.5 mg/kg/Day | Two P005672-HCl 50 mg capsules, taken orally each day | 0 | 70 | 8 | 70 | ||
| EG003 | P005672-HCl Approximately 3.0 mg/kg/Day | Two P005672-HCl 100 mg capsules, taken orally each day | 0 | 66 | 7 | 66 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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The data obtained in this study are the property of the Sponsor, any manuscript or other presentation of data must first be reviewed by the Sponsor before its submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thearpeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| C000629276 | sarecycline |
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| Female |
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| Not Hispanic or Latino |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific islander |
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| White |
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| Difference in Least Squares Means |
| 4.46 |
| 2-Sided |
| 95 |
| 0.52 |
| 8.40 |
| Superiority |
| ANCOVA | 0.0317 | Difference in Least Squares Means | 4.37 | 2-Sided | 95 | 0.39 | 8.36 | Superiority |
Two P005672-HCl 100 mg capsules, taken orally each day
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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Two P005672-HCl 100 mg capsules, taken orally each day
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| Failure |
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| Failure |
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| Failure |
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| Failure |
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| Failure |
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