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The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adapalene-BPO + Doxycyline |
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| 2 | Active Comparator | Vehicle + Doxycycline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene BPO Gel associated with Doxycyline Hyclate | Drug | Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Lesion Counts at Week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | Week 12 | |
| Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | Week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Stein Gold, MD | Henry Ford Medical Center-New Center One, Detroit, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Oceanside | California | United States | |||
| Galderma Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Recruitment period: 18 AUG 2008 to 14 NOV 2008 in thirty-five centers (30 in the USA and 5 in Canada) public or private practices. Twenty-five 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 + Doxycycline | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. |
| FG001 | Vehicle + Doxycycline | Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle Gel associated with Doxycycline Hyclate | Drug | Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks. |
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| Success Rate on the Investigator's Global Assessment |
Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12 |
| Week 12 |
| Percent of Subjects With Adverse Events | Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period) | Up to 12 weeks |
| San Diego |
| California |
| United States |
| Galderma Investigational Site | 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 + Doxycycline | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. |
| BG001 | Vehicle + Doxycycline | Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet |
| 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 |
| ||||||||||||||||||
| 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 | Percent Change From Baseline in Total Lesion Counts at Week 12. | ITT, LOCF | Posted | Feb 2010 | Median | Full Range | % of change | Week 12 |
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| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. | ITT, LOCF | Posted | Median | Full Range | % of change | Week 12 |
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| Secondary | Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 | ITT, LOCF | Posted | Feb 2010 | Median | Full Range | % of change | Week 12 |
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| Secondary | Success Rate on the Investigator's Global Assessment | Percentage of subjects graded "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12 | ITT, LOCF | Posted | Number | % of subjects | Week 12 |
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| ||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Adverse Events | Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period) | ITT | Posted | Feb 2010 | Number | % of subjects | Up to 12 weeks |
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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 + Doxycycline | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet. | 0 | 232 | 43 | 232 | ||
| EG001 | Vehicle + Doxycycline | Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet | 0 | 227 | 48 | 227 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
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| nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| vomiting | Gastrointestinal disorders | Non-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 | |
|---|---|---|---|---|
| Jean-Charles Dhuin, Clinical Project Manager | Galderma | +33 4 92 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 |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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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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