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This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adapalene/Benzoyl Peroxide Topical Gel |
|
| 2 | Active Comparator | Adapalene Topical Gel |
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| 3 | Active Comparator | Benzoyl Peroxide Topical Gel |
|
| 4 | Placebo Comparator | Topical Gel Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/Benzoyl Peroxide | Drug | Topical Gel, One application daily in the evening for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate on the Investigator's Global Assessment | Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe) | at week 12 |
| Changes in Inflammatory Lesion Counts | Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts | from Baseline to week 12 |
| Changes in Noninflammatory Lesion Counts | Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count | from Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Inflammatory Lesion Counts | Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | at week 12 |
| Percent Change in Noniflammatory Lesion Counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Graeber, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affliated Research Center | Huntsville | Alabama | 35801 | United States | ||
| Dermatology Research of Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12963896 | Background | Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x. |
| Label | URL |
|---|---|
| Related Info | View source |
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The specified washout period up to Baseline for TOPICAL facial treatments was 1 week (light therapy/exfoliation/blackhead removal) or 2 weeks (anti-inflammatory drugs/salicylic acid/steroids/antibiotics/laser) and for SYSTEMIC medications was 2 weeks (anti-inflammatory drugs), 4 Weeks (steroids/antibiotics), or 6 months (anti-acne/contraceptives).
Recruitment period: First Subject Enrolled October 2006, Last Subject Enrolled July 2007.
Types of locations: Dermatology Clinics, Dermatology Research Centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene/Benzoyl Peroxide Gel | Adapalene/Benzoyl Peroxide Topical Gel |
| FG001 | Adapalene Gel | Adapalene Topical Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adapalene |
| Drug |
Topical Gel,One application daily in the evening for 12 weeks |
|
| Benzoyl Peroxide | Drug | Topical Gel, one application daily in the evening for 12 weeks |
|
| Topical Gel Vehicle | Drug | Topical Gel Vehicle,one application daily in the evening for 12 weeks |
|
Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100
| at week 12 |
| Percent Change in Total Lesion Counts | Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | at week 12 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Associates in research, Inc. | Fresno | California | 93720 | United States |
| University of California, Irvine | Irvine | California | 92697-1385 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Marcia J. Glenn, MD and Associates, Dermatology & Laser center, Inc | Marina del Rey | California | 90292 | United States |
| Affiliated Research Institute | San Diego | California | 92108 | United States |
| University at San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Radiant Research | Santa Rosa | California | 95405 | United States |
| Dr Weintraub James | Simi Valley | California | 93065 | United States |
| The George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Visions Clinical Research | West Palm Beach | Florida | 33406 | United States |
| Atlanta Dermatology and Vein Research Center | Alpharetta | Georgia | 30005 | United States |
| SKINQRI | Lincolnshire | Illinois | 60069 | United States |
| Welborn Clinic | Evansville | Indiana | 47713 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Hamzavi Dermatology | Port Huron | Michigan | 48060 | United States |
| Somerset Skin Clinic | Troy | Michigan | 48084 | United States |
| James Del Rosso, DO - Office of Dr. James Del Russo | Henderson | Nevada | 89052 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Skin Specialty Group | New York | New York | 10021 | United States |
| Derm Research Center of NY, Inc. | Stony Brook | New York | 11790-2598 | United States |
| Zoe Draelos | High Point | North Carolina | 27262 | United States |
| OU Health Sciences Center - Dept. of Dermatology | Oklahoma City | Oklahoma | 73104 | United States |
| Allergy, Asthma and Dermatology Research Center, LLC | Lake Oswego | Oregon | 97035 | United States |
| Radiant Research | Anderson | South Carolina | 29621 | United States |
| Dermatology Associates of Knoxville | Knoxville | Tennessee | 37934 | United States |
| Arlington Center for Dermatology | Arlington | Texas | 76011 | United States |
| UTSW Medical Center at Dallas | Dallas | Texas | 75390-9190 | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| The Dermatology Centre | Calgary | Alberta | T2S 3B3 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Guildford Dermatology Specialists | Surrey | British Columbia | BC V3R 6A7 | Canada |
| Derm Research @ 888 Inc. | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| Winnipeg Clinic | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Dermadvances Research | Winnipeg | Manitoba | R3C 1R4 | Canada |
| Nexus clinical research | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| NewLab Clinical Research | St. John's | Newfoundland and Labrador | A1B 4S8 | Canada |
| Ultranova Skin care | Barrie | Ontario | L4M 6L2 | Canada |
| Lynderm Research inc. | Markham | Ontario | L3P 1A8 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| XLR8 Medical Research Inc. | Windsor | Ontario | N8W 1E6 | Canada |
| Innovaderm Research Laval Inc. | Laval | Quebec | H7S 2C6 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
| Siena Medical Research | Montreal | Quebec | H3G1C6 | Canada |
| Licca Clinical Research Institute | Augsburg | 86179 | Germany |
| Henrik Pres | Berlin | 10435 | Germany |
| Meike Schroeder | Berlin | 14169 | Germany |
| Beatrice Gerlach | Dresden | 01097 | Germany |
| Kloverkorn, Windfried | Gilching | 82205 | Germany |
| Otto-Von-Guericke-Universitat Magdeburg | Magdeburg | 39120 | Germany |
| Michael Sebastian | Mahlow | 15831 | Germany |
| Thomas Dirschka | Wuppertal | 42275 | Germany |
| Outpatient Dermatology Department DUH | Budapest | 1036 | Hungary |
| Margit Simola | Budapest | 1084 | Hungary |
| Outpatient Dermatilogy Department XIX District | Budapest | 1195 | Hungary |
| Waldemar Placek | Bydgoszcz | 85096 | Poland |
| DERMED Specjalistyczne Gabinety Lekarskie | Lodz | 90265 | Poland |
| Wojceiech Silny | Poznan | 60355 | Poland |
| FG002 | Benzoyl Peroxide Gel | Benzoyl Peroxide Topical Gel |
| FG003 | Gel Vehicle | Topical Gel Vehicle |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene/Benzoyl Peroxide Gel | Adapalene/Benzoyl Peroxide Topical Gel |
| BG001 | Adapalene Gel | Adapalene Topical Gel |
| BG002 | Benzoyl Peroxide Gel | Benzoyl Peroxide Topical Gel |
| BG003 | Gel Vehicle | Topical Gel Vehicle |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 on the Investigator's Global Assessment | Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe) | Intention to treat (ITT), last observation carried forward (LOCF). | Posted | Number | Percentage of participants | at week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Changes in Inflammatory Lesion Counts | Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts | ITT, LOCF | Posted | Median | Full Range | Lesion count | from Baseline to week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Changes in Noninflammatory Lesion Counts | Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count | ITT, LOCF | Posted | Median | Full Range | Lesion count | from Baseline to week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Inflammatory Lesion Counts | Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | ITT, LOCF | Posted | Mean | Standard Deviation | Percent change | at week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Noniflammatory Lesion Counts | Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | ITT, LOCF | Posted | Mean | Standard Deviation | Percent change | at week 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total Lesion Counts | Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | ITT, LOCF | Posted | Mean | Standard Deviation | Percent change | at 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/Benzoyl Peroxide Gel | Adapalene/Benzoyl Peroxide Topical Gel | 3 | 419 | 90 | 419 | ||
| EG001 | Adapalene Gel | Adapalene Topical Gel | 1 | 418 | 60 | 418 | ||
| EG002 | Benzoyl Peroxide Gel | Benzoyl Peroxide Topical Gel | 1 | 415 | 35 | 415 | ||
| EG003 | Gel Vehicle | Topical Gel Vehicle | 2 | 418 | 22 | 418 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Furuncle | Infections and infestations | MedDRA (6.1) |
| ||
| Appendicitis | Infections and infestations | MedDRA (6.1) |
| ||
| Abscess limb | Infections and infestations |
| |||
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (6.1) |
| ||
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (6.1) |
| ||
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) |
| ||
| Schizoaffective disorder | Psychiatric disorders | MedDRA (6.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (6.1) |
|
Following the expiration of twenty-four (24) months after the completion of the Study, Investigator shall have the right to publish the results of the Study; provided, however that Sponsor shall have the right to review any proposed publication generated from the Study prior to publication or presentation. The Sponsor shall have the absolute right to refuse the publication altogether, to delay it or to amend its contents as it deems fit.
| 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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| Between 18 and 64 years |
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| >=65 years |
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| Male |
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| Canada |
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| Europe |
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