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A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.2% Facial Cream | Experimental | 1.2% JNJ 10229570-AAA |
|
| 2.4% Facial Cream | Experimental | 2.4% JNJ 10229570-AAA |
|
| 3.6% Facial Cream | Experimental | 3.6% JNJ 10229570-AAA |
|
| 0% Facial Cream | Placebo Comparator | Vehicle control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.2% JNJ 10229570-AAA | Drug | 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Acne Lesion Counts | Change in lesion counts between baseline and end of study | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Non-inflammatory Acne Lesion Counts | Change in sum of open and closed comedones. | Baseline through Week 12 |
| Change From Baseline in the Inflammatory Acne Lesion Counts |
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Inclusion Criteria:
12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
If female of childbearing potential, must take a pregnancy test and have a negative result
Females of childbearing potential must also agree to use an adequate method of birth control, which would include:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States | ||
| University Clinical Trials, Inc. |
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| Label | URL |
|---|---|
| FDA's Drug Finder | View source |
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male and female subjects with moderate facial acne vulgaris, who met the entry criteria, were randomized with equal allocation to either 1.2%, 2.4%, or 3.6% JNJ 10229570-AAA cream or color-matched vehicle
18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | 0% Facial Cream | Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks |
| FG001 | 1.2% Facial Cream | 1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 2.4% JNJ 10229570-AAA | Drug | 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks |
|
|
| 3.6% JNJ 10229570-AAA | Drug | 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks |
|
|
| Vehicle control | Other | Color matched cream vehicle, applied once daily to the face for 12 weeks |
|
|
Change in sum of papules and pustules
| Baseline through Week 12 |
| Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones) | Baseline through Week 12 |
| Percent Change From Baseline in the Inflammatory Acne Lesion Counts | Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules) | Baseline through Week 12 |
| Percent Change From Baseline in Total Acne Lesion Counts | Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions) | Baseline through Week 12. |
| San Diego |
| California |
| 92123 |
| United States |
| Thomas J. Stephens & Associates, Inc. | Colorado Springs | Colorado | 80915 | United States |
| Horizons Clinical Research Ctr., LLC | Denver | Colorado | 80220 | United States |
| North Florida Dermatology | Jacksonville | Florida | 32204 | United States |
| Hilltop Research | St. Petersburg | Florida | 33710 | United States |
| Gwinnett Clinical Research | Snellville | Georgia | 30078 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Dermatology Specialists Research, Inc | Louisville | Kentucky | 40202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| TKL Research | Rochelle Park | New Jersey | 07662 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Hilltop Research | Miamiville | Ohio | 45147 | United States |
| Penn State Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Yardley Dermatology Associates | Yardley | Pennsylvania | 19067 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Reliance Clinical Testing Services | Irving | Texas | 75062 | United States |
| FG002 | 2.4% Facial Cream | 2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks |
| FG003 | 3.6% Facial Cream | 3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0% Facial Cream | Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks |
| BG001 | 1.2% Facial Cream | 1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks |
| BG002 | 2.4% Facial Cream | 2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks |
| BG003 | 3.6% Facial Cream | 3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks |
| 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: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Change in Total Acne Lesion Counts | Change in lesion counts between baseline and end of study | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Non-inflammatory Acne Lesion Counts | Change in sum of open and closed comedones. | Posted | Mean | Standard Deviation | Lesions | Baseline through Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Inflammatory Acne Lesion Counts | Change in sum of papules and pustules | Posted | Mean | Standard Deviation | Lesions | Baseline through Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts | Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones) | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in the Inflammatory Acne Lesion Counts | Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules) | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Acne Lesion Counts | Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions) | Posted | Mean | Standard Deviation | Percent change | Baseline through Week 12. |
|
Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
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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 | 0% Facial Cream | Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks | 0 | 106 | 21 | 106 | ||
| EG001 | 1.2% Facial Cream | 1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks | 0 | 109 | 17 | 109 | ||
| EG002 | 2.4% Facial Cream | 2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks | 0 | 109 | 14 | 109 | ||
| EG003 | 3.6% Facial Cream | 3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks | 0 | 107 | 15 | 107 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Application Site Pruritis | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Valeant | 908 927-1162 | johnson.varughese@bauschhealth.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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