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The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adapalene/benzoyl peroxide | Active Comparator | Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks |
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| Topical Gel Vehicle | Placebo Comparator | Topical Gel Vehicle applied topically once daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalene/benzoyl peroxide | Drug | daily topical application for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) |
| Change From Baseline in Total Lesion Counts | Baseline to Week 12 (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Lesion Counts From Baseline | Baseline to Week 12 (LOCF) | |
| Change in Inflammatory Lesion Counts From Baseline | Baseline to Week 12 (LOCF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Lorne Albrecht, MD | Guildford Dermatology Specialists | Principal Investigator |
| Zoe Draelos, MD | Zoe Draelos, MD | Principal Investigator |
| Lawrence Eichenfield, MD | Childrens Hospital and Health Center Division of Pediatric and Adolescent Dermatology | Principal Investigator |
| Boni Elewski, MD | UAB Dermatology Clinical Research | Principal Investigator |
| Alan Fleischer, MD | Department of Dermatology Wake Forest University Health Sciences | Principal Investigator |
| Francisco Flores, MD | FXM Research Miramar | Principal Investigator |
| Joseph Fowler, MD | Dermatology Specialists Research | Principal Investigator |
| Robert Haber, MD | Haber Dermatology Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Dermatology Clinical Research | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital and Health Center Division of Pediatric and Adolescent Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene/Benzoyl Peroxide | Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks |
| FG001 | Topical Gel Vehicle | Topical Gel Vehicle applied topically once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Topical Gel Vehicle | Drug | daily topical application for 12 weeks |
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| Adelaide Hebert, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Michael Heffernan, MD | Central Dermatology, PC | Principal Investigator |
| David Kaplan, MD | Adult & Pediatric Dermatology | Principal Investigator |
| Steven Kempers, MD | Minnesota Clinical Study Center A Division of Associated Skin Care Specialist, PA | Principal Investigator |
| Rodion Kunynetz, MD | Ultranova Skincare | Principal Investigator |
| Ian Landells, MD | Nexus Clinical Research | Principal Investigator |
| Charles Lynde, MD | Lynderm Research Inc. | Principal Investigator |
| Russell Mader, MD | Dermatology Associates of Kingsport, PC | Principal Investigator |
| Lew Andrew Rosoph, MD | North Bay Dermatology Centre | Principal Investigator |
| Joel Schlessenger, MD | Skin Specialists, PC | Principal Investigator |
| Michael Spigarelli, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Linda Stein Gold, MD | Henry Ford Health Systems - Department of Dermatology | Principal Investigator |
| Jeffrey Sugarman, MD | Redwood Family Dermatology | Principal Investigator |
| William Werschler, MD | Premier Clinical Research | Principal Investigator |
| Patricia Westmoreland, MD | Palmetto Clinical Trial Services, LLC | Principal Investigator |
| Andrea Zaenglein, MD | Penn State Milton S. Hershey Medical Center - Penn State College of Medicine | Principal Investigator |
| George Murakawa, MD | Dermcenter PC; Somerset Skin Centre | Principal Investigator |
| San Diego |
| California |
| 92123 |
| United States |
| Redwood Family Dermatology | Santa Rosa | California | 95403 | United States |
| FXM Research Miramar | Miramar | Florida | 33027 | United States |
| Adult & Pediatric Dermatology | Overland Park | Kansas | 66211 | United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40202 | United States |
| Henry Ford Health Systems Department of Dermatology | Detroit | Michigan | 48202 | United States |
| Dermcenter PC - Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Minnesota Clinical Study Center A Division of Associated Skin Care Specialists, PA | Fridley | Minnesota | 55432 | United States |
| Central Dermatology PC | St Louis | Missouri | 63117 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Zoe Draelos, MD | High Point | North Carolina | 27262 | United States |
| Department of Dermatology - Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Cininnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Haber Dermatology Clinical Research Center | South Euclid | Ohio | 44118 | United States |
| Penn State Milton S. Hershey Medical Center - Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29607 | United States |
| Dermatology Associates of Kingsport, PC | Kingsport | Tennessee | 37660 | United States |
| The University of Texas Health Sciences Center at Houston | Houston | Texas | 77030 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Guildford Dermatology Specialists | Surrey | British Columbia | V3R 6A7 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M 6L2 | Canada |
| Lynderm Research, Inc | Markham | Ontario | L3P 1A8 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene/Benzoyl Peroxide | Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks |
| BG001 | Topical Gel Vehicle | Topical Gel Vehicle applied topically once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | 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 | Success Rate | Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) | Intent to treat (ITT) population, LOCF | Posted | Number | percentage of participant | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) |
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| Primary | Change From Baseline in Total Lesion Counts | ITT population, LOCF | Posted | Mean | Standard Deviation | lesion count change | Baseline to Week 12 (LOCF) |
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| Secondary | Percent Change in Total Lesion Counts From Baseline | ITT Population, LOCF | Posted | Mean | Standard Deviation | percentage of change in lesion count | Baseline to Week 12 (LOCF) |
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| Secondary | Change in Inflammatory Lesion Counts From Baseline | ITT Population, LOCF | Posted | Mean | Standard Deviation | lesion count change | Baseline to Week 12 (LOCF) |
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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 | Adapalene/Benzoyl Peroxide | Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks | 0 | 142 | 37 | 142 | ||
| EG001 | Topical Gel Vehicle | Topical Gel Vehicle applied topically once daily for 12 weeks | 1 | 143 | 18 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RIGHT FRONTAL ARTERIOVENOUS MALFORMATION | Congenital, familial and genetic disorders | MedDRA 11.0 | Non-systematic Assessment | occurred on Day 2, resolved on Day 29 and the subject completed the study as planned.Severe, nonrelated Adverse Events (AE), Inpatient hospitalization. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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LOCF data were used for primary efficacy and secondary efficacy data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber, MD | Galderma | 609-860-8201 | michael.graeber@galderma.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 |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
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| >=65 years |
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| Male |
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| Canada |
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