A Study of a New Drug Treatment for Acne
This study has been completed.
Sponsor:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01326780
First received: March 30, 2011
Last updated: December 21, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: 1.2% JNJ 10229570-AAA Drug: 2.4% JNJ 10229570-AAA Drug: 3.6% JNJ 10229570-AAA Other: Vehicle control |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris |
Resource links provided by NLM:
Further study details as provided by Valeant Pharmaceuticals International, Inc.:
Primary Outcome Measures:
- Change in Total Acne Lesion Counts [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Change in lesion counts between baseline and end of study
Secondary Outcome Measures:
- Change from Baseline in the Non-inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change in sum of open and closed comedones.
- Change from Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change in sum of papules and pustules
- Change from Baseline in Intermediate Total Acne Lesion Count [ Time Frame: Baseline through Week 10 ] [ Designated as safety issue: No ]Change in sum of inflammatory and non-inflammatory lesions throughout the study.
- Percent Change from Baseline in the Non-Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Percent Change in sum of open and closed comedones.
- Percent Change from Baseline in the Inflammatory Acne Lesion Counts [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Percent Change in sum of of papules and pustules.
- Percent Change from Baseline in Total Acne Lesion Counts [ Time Frame: Baseline through Week 12. ] [ Designated as safety issue: No ]Percent change in inflammatory lesions and non-inflammatory lesions
- Dichotomized Assessment of Improvement of Two Grades from Baseline Score [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change from baseline in weekly Investigator's Global Assessment (IGA) scores, proportion of success according to Improvement of two grades from the baseline score
- Dichotomized Assessment of Changes from Baseline in Clear or Almost Clear Grades [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change from baseline in weekly IGA scores, proportion of success according to Clear or almost clear (Grades 0 or 1)
- Changes in Combined Investigator's Global Assessment of Acne Severity (IGA) Score [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change from baseline in weekly IGA scores, proportion of success according to dichotomized IGA using a combination of the following criteria: a) Improvement of two grades from the baseline score, b) Clear or almost clear (Grades 0 or 1)
| Enrollment: | 431 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1.2% Facial Cream
1.2% JNJ 10229570-AAA
|
Drug: 1.2% JNJ 10229570-AAA
1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
|
|
Experimental: 2.4% Facial Cream
2.4% JNJ 10229570-AAA
|
Drug: 2.4% JNJ 10229570-AAA
2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
|
|
Experimental: 3.6% Facial Cream
3.6% JNJ 10229570-AAA
|
Drug: 3.6% JNJ 10229570-AAA
3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
Other Name: Not yet marketed
|
|
Placebo Comparator: 0% Facial Cream
Vehicle control
|
Other: Vehicle control
Color matched cream vehicle, applied once daily to the face for 12 weeks
Other Name: Not marketed
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
- Condom with spermicide
- IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods
Exclusion Criteria:
- Known sensitivity to any of the ingredients in the study medication
- More than 3 nodulocystic acne lesions
- Use of acne treatments, therapies or medications within protocol-specified timeframes
- Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
- Excessive facial hair that may interfere with application of the medication and/or evaluations
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326780
Locations
| United States, California | |
| University of California, San Diego | |
| San Diego, California, United States, 92093 | |
| University Clinical Trials, Inc. | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Thomas J. Stephens & Associates, Inc. | |
| Colorado Springs, Colorado, United States, 80915 | |
| Horizons Clinical Research Ctr., LLC | |
| Denver, Colorado, United States, 80220 | |
| United States, Florida | |
| North Florida Dermatology | |
| Jacksonville, Florida, United States, 32204 | |
| Hilltop Research | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Georgia | |
| Gwinnett Clinical Research | |
| Snellville, Georgia, United States, 30078 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kentucky | |
| Dermatology Specialists Research, Inc | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, New Jersey | |
| TKL Research | |
| Rochelle Park, New Jersey, United States, 07662 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, North Carolina | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Hilltop Research | |
| Miamiville, Ohio, United States, 45147 | |
| United States, Pennsylvania | |
| Penn State Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Yardley Dermatology Associates | |
| Yardley, Pennsylvania, United States, 19067 | |
| United States, Texas | |
| Research Across America | |
| Dallas, Texas, United States, 75234 | |
| Reliance Clinical Testing Services | |
| Irving, Texas, United States, 75062 | |
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
| Study Director: | David Lineberry | Valeant Pharmaceuticals International, Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT01326780 History of Changes |
| Other Study ID Numbers: | CA-P-8023 |
| Study First Received: | March 30, 2011 |
| Last Updated: | December 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
|
Acne Irritation Safety Sebum |
Additional relevant MeSH terms:
|
Acne Vulgaris Acneiform Eruptions Skin Diseases Facial Dermatoses Sebaceous Gland Diseases |
ClinicalTrials.gov processed this record on May 23, 2013