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A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9 to 11 is safe and efficacious.
Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled in this randomized, double blind, multi-center study.
Following satisfaction of entry criteria and screening procedures, subjects will receive either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the 12-week treatment period. Subjects will be monitored for safety throughout the study and for signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at study completion, week 12.
Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be taken at Baseline and weeks 2, 4, 8 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retin-A Micro | Experimental | Retin-A Micro 0.04% facial acne treatment used once daily |
|
| Vehicle Control | Placebo Comparator | Color matched facial gel vehicle control used once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retin-A Micro 0.04% facial acne treatment | Drug | Retin-A Micro 0.04% facial acne treatment used once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Non-inflammatory Lesion Count | Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Lesion Counts | Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Rossi, MD | Johnson & Johnson Consumer and Personal Products Worldwide | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encino Research Center | Encino | California | 91436 | United States | ||
| Children's Hospital and Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22712470 | Derived | Eichenfield LF, Hebert AA, Schachner L, Paller AS, Rossi AB, Lucky AW. Tretinoin microsphere gel 0.04% pump for treating acne vulgaris in preadolescents: a randomized, controlled study. Pediatr Dermatol. 2012 Sep-Oct;29(5):598-604. doi: 10.1111/j.1525-1470.2012.01811.x. Epub 2012 Jun 19. |
| Label | URL |
|---|---|
| FDA's Drug Finder | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retin-A Micro | Retin-A Micro 0.04% facial acne treatment used once daily |
| FG001 | Vehicle Control | Color matched facial gel vehicle control used once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Vehicle control | Drug | Color-matched facial gel vehicle control used once daily |
|
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| Baseline to Week 12 |
| Measurement of Success 1 | Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. | Week 12 |
| Measurement of Success 2 | Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. | Week 12 |
| Measurement of Success 3 | Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores. | Week 12 |
| Global Assessment | Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. | Baseline to Week 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Department of Dermatology, University of Miami | Miami | Florida | 33136 | United States |
| Department of Dermatology, Northwestern University | Chicago | Illinois | 60611 | United States |
| Dermatology Associates | Louisville | Kentucky | 40202 | United States |
| UMDNJ-RWJ Medical School | Somerset | New Jersey | 08873 | United States |
| SUNY Downstate Medical Center Department of Dermatology | Brooklyn | New York | 11203 | United States |
| Dermatology Research Associates | Cincinnatti | Ohio | 45230 | United States |
| Skin Study Center | Broomall | Pennsylvania | 19008 | United States |
| Yardley Dermatology Associates | Yardley | Pennsylvania | 19067 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| University of Texas Medical School at Houston | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Retin-A Micro | Retin-A Micro 0.04% facial acne treatment used once daily |
| BG001 | Vehicle Control | Color matched facial gel vehicle control used once daily |
| 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, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||
| Subject Reached Puberty | 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 |
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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 From Baseline in Total Non-inflammatory Lesion Count | Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline to Week 12 |
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| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lesion Counts | Change from baseline in Lesion Count by the following categories: Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. Inflammatory lesions were the sum of papules and pustules. Total lesions were the sum of non-inflammatory and inflammatory lesions, plus nodules/cysts. For each lesion type, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement. | Posted | Least Squares Mean | Standard Error | Lesions | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Measurement of Success 1 | Participants achieving success according to the Investigator Global Assessment (IGA #1) - (Pediatric Acne Scale) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), severe (4), and very severe (5). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. | Posted | Number | Participants | Week 12 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Measurement of Success 2 | Participants achieving success according to dichotomized Investigator Global Assessment (IGA) scores - Food and Drug Administration Score (IGA#2) The IGA #2 (static 5 point scale recommended in the FDA acne guidelines) has ordinal response categories identified as clear (0), almost clear (1), mild (2), moderate (3), and severe (4). The number of participants for which treatment was considered successful was based on 2 criteria: 1) improvement by at least 2 grades from the baseline score, and 2) ratings of clear or almost clear. | Posted | Number | Participants | Week 12 |
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| Secondary | Measurement of Success 3 | Participants achieving success according to Investigator Global Assessment (IGA#3) scores. At Week 12, the IGA #3 rated the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. The number of participants for which treatment was considered successful was based on the IGA #3 success criteria defined as achievement of "Excellent" or "Good" scores. | Posted | Number | Participants | Week 12 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Global Assessment | Participants showing improvement from baseline in the Investigator's Global Assessment, in the Intent to Treat population using the Last Available Measurement and imputation technique of Last Observation Carried Forward, rating the subject's improvement over Baseline by using the following categories: Excellent, Good, Fair, No Change, Worse. | Posted | Number | Participants | Baseline to Week 12 |
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12 Weeks
Subjects asked if they experienced adverse events at each visit.
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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 | Retin-A Micro | Retin-A Micro 0.04% facial acne treatment used once daily | 0 | 55 | 25 | 55 | ||
| EG001 | Vehicle Control | Color matched facial gel vehicle control used once daily | 1 | 55 | 7 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Lineberry, Associate Director, Clinical Operations | 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 |
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| ID | Term |
|---|---|
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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| Title | Measurements |
|---|---|
|
| 11 Years |
|
| Male |
|
| No |
|
| II |
|
| III |
|
| IV |
|
| V |
|
| VI |
|
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