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The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily |
|
| 2 | Placebo Comparator | Vehicle Gel once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel | Drug | Topical Gel to the face, once daily in the evening for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance Success for Total Lesions at Week 24 | Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance Success for Inflamatory Lesions at Week 24 | Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts. | Week 24 |
| Maintenance Success for Non-inflammatory Lesions at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Thiboutot, MD | Penn State College of Medicine, Hershey, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | San Diego | California | United States | |||
| Galderma Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Recruitment period: 12 NOV 2008 to 09 FEB 2009 in thirty-four centers (29 in the USA and 5 in Canada) public or private practices. Twenty-four USA centers and four Candadian centers used a central IRB, and the others used a local IRB.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene-BPO | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel |
| FG001 | Vehicle | Vehicle Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Gel | Drug | Topical Gel to the face, once daily in the evening for 24 weeks. |
|
Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts. |
| Week 24 |
| Investigator Global Assessment (IGA) Maintenance Success at Week 24 | IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade. IGA grade: 0 Clear:Residual hyperpigmentation & erythema may be present
| Baseline, Week 24 |
| Percent of Subjects With Adverse Events | All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent | Up to 24 weeks |
| Denver |
| Colorado |
| United States |
| Galderma Investigational Site | Longmont | Colorado | United States |
| Galderma Investigational Site | Miami | Florida | United States |
| Galderma Investigational Site | Snellville | Georgia | United States |
| Galderma Investigational Site | Chicago | Illinois | United States |
| Galderma Investigational Site | Evansville | Indiana | United States |
| Galderma Investigational Site | Overland Park | Kansas | United States |
| Galderma Investigational Site | Louisville | Kentucky | United States |
| Galderma Investigational Site | Detroit | Michigan | United States |
| Galderma Investigational Site | Fort Gratiot | Michigan | United States |
| Galderma Investigational Site | Fridley | Minnesota | United States |
| Galderma Investigational Site | Omaha | Nebraska | United States |
| Galderma Investigational Site | Albuquerque | New Mexico | United States |
| Galderma Investigational Site | Stony Brook | New York | United States |
| Galderma Investigational Site | Winston-Salem | North Carolina | United States |
| Galderma Investigational Site | Warren | Ohio | United States |
| Galderma Investigational Site | Hazleton | Pennsylvania | United States |
| Galderma Investigational Site | Hershey | Pennsylvania | United States |
| Galderma Investigational Site | Simpsonville | South Carolina | United States |
| Galderma Investigational Site | Arlington | Texas | United States |
| Galderma Investigational Site | Austin | Texas | United States |
| Galderma Investigational Site | College Station | Texas | United States |
| Galderma Investigational Site | Houston | Texas | United States |
| Galderma Investigational Site | Lubbock | Texas | United States |
| Galderma Investigational Site | San Antonio | Texas | United States |
| Galderma Investigational Site | Webster | Texas | 77598 | United States |
| Galderma Investigational Site | Barrie | Ontario | Canada |
| Galderma Investigational Site | North Bay | Ontario | Canada |
| Galderma Investigational Site | Windsor | Ontario | Canada |
| Galderma Investigational Site | Québec | Quebec | Canada |
| Galderma Investigational Site | Aibonito | Puerto Rico |
| Galderma Investigational Site | Carolina | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene-BPO | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel |
| BG001 | Vehicle | Vehicle Gel |
| 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 |
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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 | Maintenance Success for Total Lesions at Week 24 | Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts. | ITT - Worst-case (Any missing data at Week 24 is considered as a failure) | Posted | Jul 2010 | Number | percent of subjects | Week 24 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Maintenance Success for Inflamatory Lesions at Week 24 | Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts. | ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success) | Posted | Jul 2010 | Number | percent of subjects | Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Maintenance Success for Non-inflammatory Lesions at Week 24 | Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts. | ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success) | Posted | Jul 2010 | Number | percent of subjects | Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Investigator Global Assessment (IGA) Maintenance Success at Week 24 | IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade. IGA grade: 0 Clear:Residual hyperpigmentation & erythema may be present
| ITT - Worst-case (Any missing data at each visit is considered as a failure, except where maintenance rate of both previous and following visits are success) | Posted | Jul 2010 | Number | percent of subjects | Baseline, Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Adverse Events | All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent | Posted | Jul 2010 | Number | percent of subjects | Up to 24 weeks |
|
|
6 months
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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-BPO | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel | 1 | 123 | 43 | 123 | ||
| EG001 | Vehicle | Vehicle Gel | 1 | 120 | 27 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar disorder | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pilonidal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma | +33 492 95 29 21 | jean-charles.dhuin@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 |
|---|---|
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| >=65 years |
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| Male |
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| Puerto Rico |
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| Canada |
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