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The study hypothesis are based on the assumption that :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD0271 0.3% /CD1579 2.5% Gel | Experimental | active arm |
|
| CD0271 0.1% / CD1579 2.5% | Active Comparator | Comparator arm |
|
| Topical Gel Vehicle | Placebo Comparator | Placebo arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD0271 0.3% / CD1579 2.5% | Drug |
| ||
| CD0271 0.1% / CD1579 2.5% |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets. | Week 12 |
| Changes From Baseline in Inflammatory Lesion Counts | Baseline - Week12 | |
| Changes From Baseline in Non-Inflammatory Lesion Counts | Baseline - Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational site | Birmingham | Alabama | United States | |||
| Galderma Investigationnal Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28686776 | Derived | Stein Gold L, Werschler WP, Mohawk J. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender. J Drugs Dermatol. 2017 Jun 1;16(6):582-589. | |
| 28686775 | Derived | Alexis AF, Cook-Bolden FE, York JP. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: A Safe and Effective Acne Therapy in All Skin Phototypes. J Drugs Dermatol. 2017 Jun 1;16(6):574-581. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CD0271 0.3% /CD1579 2.5% Gel | Active arm CD0271 0.3% / CD1579 2.5% |
| FG001 | CD0271 0.1% / CD1579 2.5% | Comparator arm CD0271 0.1% / CD1579 2.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Topical Gel Vehicle | Drug |
|
| Mobile |
| Alabama |
| United States |
| Galderma investigational Site | Hot Springs | Arkansas | United States |
| Galderma Investigational Site | Los Angeles | California | United States |
| Galderma Investigational Site | Sacramento | California | United States |
| Galderma Investigational Site | Santa Monica | California | United States |
| Galderma Investigational Site | Miami | Florida | United States |
| Galderma Investigational Site | Miramar | Florida | United States |
| Galderma Investiogational Site | Newnan | Georgia | United States |
| Galderma Investigational Site | Snellville | Georgia | United States |
| Galderma Investigational Site | Chicago | Illinois | United States |
| Galderma Investigational Site | Detroit | Michigan | United States |
| Galderma Investigational Site | Albuquerque | New Mexico | United States |
| Galderma Investigational Site | New York | New York | United States |
| Galderma Investigational Site | Stony Brook | New York | United States |
| Galderma Investigational Site | Raleigh | North Carolina | United States |
| Galderma Investigational Site | Beachwood | Ohio | United States |
| Galderma investigational Site | Hershey | Pennsylvania | United States |
| Galderma Investigational Site | Greenville | South Carolina | United States |
| Galderma Investigational Site | Goodlettsville | Tennessee | United States |
| Galderma Investigational Site | Knoxville | Tennessee | United States |
| Galderma Investigational Site | Arlington | Texas | United States |
| Galderma Investigational Site | San Antonio | Texas | United States |
| Galderma Investigational Site | Salt Lake City | Utah | United States |
| Galderma Investigational Site | Spokane | Washington | United States |
| Galderma Investigational Site | Barrie | Canada |
| Galderma Investigational Site | Markham | Canada |
| Galderma Investiogational Site | Montreal | Canada |
| Galderma Investigational Site | Peterborough | Canada |
| Galderma Investigational site | Surrey | Canada |
| Galderma Investigational Site | Waterloo | Canada |
| 26945741 | Derived | Stein Gold L, Weiss J, Rueda MJ, Liu H, Tanghetti E. Moderate and Severe Inflammatory Acne Vulgaris Effectively Treated with Single-Agent Therapy by a New Fixed-Dose Combination Adapalene 0.3 %/Benzoyl Peroxide 2.5 % Gel: A Randomized, Double-Blind, Parallel-Group, Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):293-303. doi: 10.1007/s40257-016-0178-4. |
| FG002 | Topical Gel Vehicle | Placebo arm Topical Gel Vehicle |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CD0271 0.3% /CD1579 2.5% Gel | Active arm CD0271 0.3% / CD1579 2.5% |
| BG001 | CD0271 0.1% / CD1579 2.5% | Comparator arm CD0271 0.1% / CD1579 2.5% |
| BG002 | Topical Gel Vehicle | Placebo arm Topical Gel Vehicle |
| BG003 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Investigator Global Assessment (IGA) | 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 | Success Rate | Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets. | Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline. | Posted | Number | percentage of participants | Week 12 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Changes From Baseline in Inflammatory Lesion Counts | ITT Population, Multiple imputation | Posted | Least Squares Mean | Standard Error | Lesions | Baseline - Week12 |
|
| |||||||||||||||||||||||||||||||||
| Primary | Changes From Baseline in Non-Inflammatory Lesion Counts | ITT Population, Multiple Imputation | Posted | Least Squares Mean | Standard Error | lesions | Baseline - Week 12 |
|
|
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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 | CD0271 0.3% /CD1579 2.5% Gel | Active arm CD0271 0.3% / CD1579 2.5% | 0 | 217 | 34 | 217 | ||
| EG001 | CD0271 0.1% / CD1579 2.5% | Comparator arm CD0271 0.1% / CD1579 2.5% | 1 | 217 | 23 | 217 | ||
| EG002 | Topical Gel Vehicle | Placebo arm Topical Gel Vehicle | 0 | 69 | 13 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalized Anxiety Disorder | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Infleunza | Infections and infestations |
| |||
| Gastroenteritis | Infections and infestations |
| |||
| Ear infection | Infections and infestations |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Skin irritation | Skin and subcutaneous tissue disorders |
| |||
| Dermatitis allergic | Skin and subcutaneous tissue disorders |
| |||
| Eczema | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Rhinitis seasonal | Nervous system disorders |
| |||
| Fatigue | General disorders |
| |||
| Pyrexia | General disorders |
| |||
| Motion sickness | Ear and labyrinth disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Galderma CPM | Galderma R&D | 00 33 4 93 95 70 70 | clinicaltrials@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 |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| United States |
|
| Baseline IGA = Severe (4) |
|
| Baseline IGA=Severe (4) (MI: Multiple Imputation) |
|
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