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| Name | Class |
|---|---|
| Dow Pharmaceutical Sciences | INDUSTRY |
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The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACYC | Active Comparator | ACYC active, topically applied to the face for 12 weeks |
|
| ACYC vehicle | Placebo Comparator | ACYC vehicle (placebo), topically applied to the face for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACYC | Drug | ACYC active, topically applied to the face for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Inflammatory Lesion Count | Baseline and 12 Weeks | |
| Absolute Change in Non-inflammatory Lesion Count | Baseline and 12 Weeks | |
| Percent of Subjects Who Have a Least a 2 Grade Reduction | Baseline and 12 Weeks | |
| Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear | Baseline and 12 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilima Justice, M.D. | Medical Monitor, Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | ACYC | ACYC active, topically applied to the face for 12 weeks |
| FG001 | ACYC Vehicle | ACYC vehicle (placebo), topically applied to the face for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ACYC vehicle |
| Drug |
ACYC vehicle (placebo), topically applied to the face for 12 weeks |
|
| Los Angeles |
| California |
| 90045 |
| United States |
| San Diego | California | 92123 | United States |
| New Haven | Connecticut | 06511 | United States |
| Aventura | Florida | 33180 | United States |
| Naperville | Illinois | 60563 | United States |
| Evansville | Indiana | 47714 | United States |
| South Bend | Indiana | 46617 | United States |
| Louisville | Kentucky | 40202 | United States |
| Clinton Township | Michigan | 48038 | United States |
| Fridley | Minnesota | 55432 | United States |
| Omaha | Nebraska | 68144 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Rochester | New York | 14623 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Portland | Oregon | 97210 | United States |
| Goodlettsville | Tennessee | 37072 | United States |
| Austin | Texas | 78759 | United States |
| College Station | Texas | 77845 | United States |
| Houston | Texas | 77056 | United States |
| San Antonio | Texas | 78250 | United States |
| Salt Lake City | Utah | 84117 | United States |
| Lynchburg | Virginia | 24501 | United States |
| Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACYC | ACYC active, topically applied to the face for 12 weeks |
| BG001 | ACYC Vehicle | ACYC vehicle (placebo), topically applied to the face for 12 weeks |
| BG002 | 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Inflammatory Lesion Count | Mean | Standard Deviation | Lesions |
| |||||||||||||||
| Non-Inflammatory Lesion Count | Mean | Standard Deviation | Lesions |
| |||||||||||||||
| Evaluator's Global Severity Score (EGSS) | Number | participants |
|
| 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 | Absolute Change in Inflammatory Lesion Count | Posted | Mean | Standard Deviation | Lesion count | Baseline and 12 Weeks |
|
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| Primary | Absolute Change in Non-inflammatory Lesion Count | Posted | Mean | Standard Deviation | lesion count | Baseline and 12 Weeks |
|
| |||||||||||||||||||||||||||||||
| Primary | Percent of Subjects Who Have a Least a 2 Grade Reduction | Posted | Number | Percent with >2% reduction | Baseline and 12 Weeks |
|
| ||||||||||||||||||||||||||||||||
| Primary | Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear | Posted | Number | percentage of clear or almost clear | Baseline and 12 Weeks |
|
|
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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 | ACYC | ACYC active, topically applied to the face for 12 weeks | 0 | 243 | 38 | 243 | ||
| EG001 | ACYC Vehicle | ACYC vehicle (placebo), topically applied to the face for 12 weeks | 0 | 236 | 31 | 236 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Exec Dir Clinical Dir | 908-927-1162 | johnson.varughese@valeant.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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Almost Clear |
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| Mild |
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| Moderate |
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| Severe |
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| Very Severe |
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