Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to determine if using 2 acne products in the morning is as safe and efficacious as using one product in the morning and one product in the evening.
Approximately 240 subjects will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, all subjects will receive RETIN-A MICRO PUMP 0.04% and a 5% Benzoyl Peroxide wash (OTC) for the entire 12-week treatment period. Subjects will be randomized to either both morning treatments (test) or to the morning/evening treatment (active control). Subjects will be assessed at baseline, at week 3, week 6 and again at the end of therapy, week 12 for number and type of individual lesions and safety. At selected sites, photographs will be taken at the same time points. At Week 12 subjects will be assessed for Investigator's Global Assessment of Acne Severity. The investigator will conduct all of the lesion counts, global assessments and safety assessments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Same time of day | Experimental | 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day |
|
| Different times of day | Active Comparator | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benzoyl peroxide wash | Drug | 5% benzoyl peroxide wash |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Facial Acne Lesion Count | Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions). | Baseline to Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Rossi, MD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | United States | ||
| International Dermatology Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20677537 | Result | Pariser D, Bucko A, Fried R, Jarratt MT, Kempers S, Kircik L, Lucky AW, Rafal E, Rendon M, Weiss J, Wilson DC, Rossi AB, Ramaswamy R, Nighland M. Tretinoin gel microsphere pump 0.04% plus 5% benzoyl peroxide wash for treatment of acne vulgaris: morning/morning regimen is as effective and safe as morning/evening regimen. J Drugs Dermatol. 2010 Jul;9(7):805-13. |
| Label | URL |
|---|---|
| FDA's Drug Finder | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Same Time of Day | 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day |
| FG001 | Different Times of Day | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tretinoin gel | Drug | 0.04% tretinoin gel |
|
|
| Measurement of Success | Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe. | Baseline to Week 12 |
| Miami |
| Florida |
| 33144 |
| United States |
| Gwinnett Clinical Research | Snellville | Georgia | 30078 | United States |
| Derm Research, PLLC | Louisville | Kentucky | 40217 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| DermResearch Center of New York | Stony Brook | New York | 11790 | United States |
| Dermatology Research Associates | Cincinnatti | Ohio | 45230 | United States |
| Yardley Dermatology Associates | Yardley | Pennsylvania | 19067 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Education & Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Same Time of Day | 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day |
| BG001 | Different Times of Day | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening |
| 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Fitzpatrick Score | Skin type is categorized according to the Fitzpatrick skin type scale, which ranges from very fair (skin type I) to very dark (skin type VI). | 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 | Change From Baseline in Total Facial Acne Lesion Count | Total Facial Acne Lesion Count is the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. Change from Baseline is calculated as the value after Baseline minus the baseline value, and negative values indicate improvement. | Per Protocol Population, which includes all Intention to Treat (ITT) subjects who completed the 12 weeks of treatment and evaluations with no major protocol deviations. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline to Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Inflammatory and Non-Inflammatory Lesion Counts and Their Totals | Between group comparison with Last Count Carried Forward (LOCF) of Inflammatory Facial Acne Lesion Count (the sum of papules and pustules), Non-Inflammatory Facial Acne Lesion Count (the sum of open and closed comedones), and their Total (the sum of Non-inflammatory and Inflammatory lesions). | Data set includes all Intent to Treat (ITT)subjects. Imputation technique was Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | Lesions | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Measurement of Success | Number of subjects achieving success according to dichotomized Investigator Global Assessment (IGA) using criteria of grades 0 or 1, or improvement of 2 grades from baseline score. Possible grades from 0-6 are described as follows: 0 = Clear, 1=Almost Clear, 2=Mild, 3=Mild to Moderate, 4=Moderate, 5=Moderately Severe, 6=Severe. | Intention to Treat (ITT)population and imputation technique of Last Observations Carried Forward (LOCF) | Posted | Number | Participants | Baseline to Week 12 |
|
|
12 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Same Time of Day | 5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day | 3 | 123 | 0 | 123 | ||
| EG001 | Different Times of Day | 5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening | 0 | 124 | 0 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Viral Myocarditis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Lineberry | Valeant Pharmaceuticals International, Inc | 949-973-1153 | David.Lineberry@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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D014260 | Triclosan |
| ID | Term |
|---|---|
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Male |
|
| II |
|
| III |
|
| IV |
|
| V |
|
| VI |
|
|
|