Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IND 076057 |
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene lotion 0.1% | Experimental |
| |
| Adapalene Lotion vehicle | Placebo Comparator |
|
| 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 |
|
| 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 Count From Baseline to Week 12 | Baseline to Week 12 | |
| 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 Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Scott Dinehart |
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 7, 2007; last subject completed Nov 6, 2008
Not provided
| 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Adapalene Lotion Vehicle | Drug | Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Dermatology and Laser Center | Marina del Rey | California | 90292 | United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| Solano Clinical Research | Vallejo | California | 94589 | United States |
| Colorado Medical Research Center | Denver | Colorado | 80210 | United States |
| Longmont Clinic | Longmont | Colorado | 80501 | United States |
| Advanced Dermatology | Clermont | Florida | 34711 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Anne M. Loebl | Augusta | Georgia | 30904 | United States |
| Scott Glazer | Buffalo Grove | Illinois | 60089 | United States |
| Sound Bend Clinic | South Bend | Indiana | 46617 | United States |
| Hamzavi Dermatology | Port Huron | Michigan | 48060 | United States |
| Central Dermatology, PC | St Louis | Missouri | 63117 | United States |
| Darmouth-Hitchcock Medical Center Section of Dermatology | Lebanon | New Hampshire | 03756 | United States |
| Academic Dermatology | Albuquerque | New Mexico | 87106 | United States |
| Elizabeth Arthur | Rochester | New York | 14609 | United States |
| Derm Research Center of New York | Stony Brook | New York | 11790 | United States |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | United States |
| Haber Dermatology & Cosmetic Research | South Euclid | Ohio | 44118 | United States |
| OU Health Sciences Center-Dept. of Dermatology | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Medical Center, PC | Portland | Oregon | 97223 | United States |
| Rivergate Dermatology | Goodlettsville | Tennessee | 37072 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Center for Clinical Studies | Houston | Texas | 77058 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| The Dermatology Centre | Calgary | Alberta | T2S 3B3 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Guildford Dermatology Specialists | Surrey | British Columbia | T3A2N1 | Canada |
| Dermadvance Research | Winnipeg | Manitoba | R3C 1R4 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| Lynderm Research, Inc. | Markham | Ontario | L3P 6L2 | Canada |
| K. Papp Clinical Research, Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| 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 |
|
| 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 |
|
| 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 |
|
|
| ||||||||||||||||||||||||||||||
| 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 Week 12 |
|
| ||||||||||||||||||||||||||||||
| Primary | Co-Primary Endpoint: Absolute Change in Total Lesion Count From Baseline to Week 12 | Posted | Least Squares Mean | Standard Error | Absolute Change in Total Lesion Count | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||
| 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 count | Baseline to Week 12 |
|
|
Not provided
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 | Adapalene Lotion 0.1% | once a day for 12 weeks | 2 | 533 | 50 | 533 | ||
| EG001 | Adapalene Lotion Vehicle 0% | once a day for 12 weeks | 2 | 542 | 21 | 542 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple drug overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| ||
| Ovarian cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Canada |
|
|
|
|
|