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| ID | Type | Description | Link |
|---|---|---|---|
| IND 076057 |
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The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.
This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene lotion 0.1% | Experimental |
| |
| Adapalene Lotion vehicle | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene lotion 0.1% | Drug | Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe. | From Baseline to Week 12 |
| Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 | Baseline to 12 weeks | |
| Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | |
| Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Percent change in lesion count from baseline to week 12 | From Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Diego | California | 92123 | United States | ||
| Dermatology Specialists, Inc. |
Washout requirements: 2 weeks for systemic anti-inflammatory drugs, 4 weeks for oral antibiotics, 2 months for inhaled/nasal steroids and 6 months for hormonal contraceptives/therapies.
Multi center study recruitment period: First subject enrolled Nov 6, 2007; last subject completed Nov 14, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene Lotion 0.1% | once a day for 12 weeks |
| FG001 | Adapalene Lotion Vehicle 0% | once a day for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Adapalene Lotion Vehicle | Drug | Vehicle will be applied topically to the face, once a day, for 12 weeks |
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| Vista |
| California |
| 92083 |
| United States |
| Cherry Creek Dermatology | Denver | Colorado | 80246 | United States |
| Advanced Dermatology and Cosmetic Surgery | Ormond Beach | Florida | 32174 | United States |
| Dermatology Research | Pinellas Park | Florida | 33781 | United States |
| Christie Clinic, PC | Champaign | Illinois | 61820 | United States |
| Compliant Clinical Research | Olathe | Kansas | 66061 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| East Coast Clinical Research, Inc. | Haverhill | Massachusetts | 01830 | United States |
| Midwest Cutaneous Research | Clinton Township | Michigan | 48038 | United States |
| Henry Ford Medical Center-Dept. of Dermatology | Detroit | Michigan | 48202 | United States |
| Minnesota Clinical Study Centert | Fridley | Minnesota | 55432 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Cindy Lamerson | Reno | Nevada | 89511 | United States |
| Fran Cook-Bolden | New York | New York | 10021 | United States |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| University Dermatology Consultants | Cincinnati | Ohio | 45219 | United States |
| Central Sooner Research | Norman | Oklahoma | 73069 | United States |
| Northwest Cutaneous Research Specialists | Portland | Oregon | 97210 | United States |
| Palmetto Medical Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Dermatology Associates | Knoxville | Tennessee | 37917 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| J&S Studies, Inc. | Bryan | Texas | 77802 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Dermatology Research Center | Salt Lake City | Utah | 84124 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Dermatology Associates | Calgary | Alberta | T3A 2N1 | Canada |
| Derm Research @ 888 Inc | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M 6L2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| Siena Medical Research | Montreal | Quebec | H3G 1C6 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene Lotion 0.1% | once a day for 12 weeks |
| BG001 | Adapalene Lotion Vehicle 0% | once a day 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 | Co-Primary Endpoint: Success Rate on Investigator's Global Assessment (IGA) From Baseline to Week 12 | Success defined as percentage of subjects who achieved at least a two-grade reduction in IGA scale (e.g from moderate to clear or almost clear)at week 12 from baseline, Last Observation Carried Forward, Intent to treat population. The IGA (Investigator Global Assessment) is defined as a 5 point scale (0 to 4). "0" = clear , "1"= almost clear, "2"= mild, "3"= moderate, "4"=severe. | Posted | Number | Percentage of Participants | From Baseline to Week 12 |
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| Primary | Co-Primary Endpoint: Absolute Change in Total Lesion Counts From Baseline to Week 12 | Posted | Least Squares Mean | Standard Error | Absolute Change in Total Lesion Count | Baseline to 12 weeks |
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| Secondary | Mean Percent Change in Total Lesion Count From Baseline to Week 12 | Percent change in lesion count from baseline to week 12 | Posted | Mean | Standard Deviation | % Change in Lesion Count | From Baseline to 12 weeks |
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| Primary | Co-Primary Endpoint: Absolute Change in Inflammatory Lesion Count From Baseline to Week 12 | Posted | Least Squares Mean | Standard Error | Absolute Change in Infl Lesion count | Baseline to Week 12 |
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| Primary | Co-Primary Endpoint: Absolute Change in NonInflammatory Lesion Counts From Baseline to Week 12 | Posted | Least Squares Mean | Standard Error | Absolute Change in Non-Infl Lesion | Baseline to 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 | Adapalene Lotion 0.1% | once a day for 12 weeks | 0 | 535 | 32 | 535 | ||
| EG001 | Adapalene Lotion Vehicle 0% | once a day for 12 weeks | 0 | 531 | 11 | 531 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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disclosure restriction varies per institutional request/agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Graeber MD/ Head of Global Clinical Project Management | 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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| >=65 years |
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| Male |
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| Canada |
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