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This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Same as above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment | Experimental | adapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adapalene gel, 0.3% | Drug | Applied once daily at bedtime |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Lesion Counts | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Severity Assessment Success | Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear | 6 and 12 weeks |
| Global Assessment of Improvement From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
1. Subjects with more than three nodulo-cystic lesions
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| Name | Affiliation | Role |
|---|---|---|
| Ron W Gottschalk, MD | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| Derm Research, P.L.L.C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Therapy | Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| clindamycin/benzoyl peroxide gel | Drug | Applied once daily in the morning |
|
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| 12 weeks |
| Worst Post Baseline Tolerability Assessment - Erythema | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | 12 weeks |
| Worst Post Baseline Tolerability Assessment - Scaling | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | 12 weeks |
| Worst Post Baseline Tolerability Assessment - Dryness | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | 12 weeks |
| Worst Post Baseline Tolerability Assessment - Burning/Stinging | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | 12 weeks |
| Louisville |
| Kentucky |
| 40217 |
| United States |
| Brodell Medical | Warren | Ohio | 44483 | United States |
| Northwest Cutaneous Research Specialists | Portland | Oregon | 97210 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Therapy | Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening. |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Duration of Acne | Mean | Standard Deviation | years |
| ||||||||||||||||||||
| Fitzpatrick Skin Type | Investigator assessment based on the standard Fitzpatrick Skin Test (Scale I to VI). Example: TYPE 1: Highly sensitive, always burns, never tans. TYPE 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown. TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented | 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 | Posted | Mean | Standard Deviation | Percent Change | 6 and 12 weeks |
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| Secondary | Global Severity Assessment Success | Global Severity was assessed on a 6 point scale (Clear, Almost Clear, Mild, Moderate, Severe). The scale was dichotomized to success or failure where success = Clear or Almost Clear | Posted | Number | participants | 6 and 12 weeks |
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| Secondary | Global Assessment of Improvement From Baseline | Posted | Number | participants | 12 weeks |
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| Secondary | Worst Post Baseline Tolerability Assessment - Erythema | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | Safety Population (n=99) | Posted | Number | participants | 12 weeks |
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| Secondary | Worst Post Baseline Tolerability Assessment - Scaling | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | Safety Population (n=99) | Posted | Number | participants | 12 weeks |
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| Secondary | Worst Post Baseline Tolerability Assessment - Dryness | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | Safety Population (n=99) | Posted | Number | participants | 12 weeks |
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| Secondary | Worst Post Baseline Tolerability Assessment - Burning/Stinging | Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF. | Safety Population (n=99) | Posted | Number | participants | 12 weeks |
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12 Weeks
Please Note: "Tolerability Assessments" were captured separately from adverse events. Tolerability changes that required a dose modification or concomitant treatment were to be recorded on the Adverse Event CRF.
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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 | Combination Therapy | Each subject applied each of the study medications once daily: Duac® Topical Gel in the morning and Differin® Gel, 0.3% in the evening. | 0 | 99 | 32 | 99 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Burn | General disorders | MedDRA | Non-systematic Assessment |
| |
| Application Site Dryness | General disorders | MedDRA | Non-systematic Assessment |
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| Application Site Erythema | General disorders | MedDRA | Non-systematic Assessment |
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| Application Site Exfoliation | General disorders | MedDRA | Non-systematic Assessment |
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| Application Site Discomfort | General disorders | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Nieman | Galderma Laboratories, L.P. | 817-961-5000 | elizabeth.nieman@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 |
|---|---|
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| III |
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| IV |
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| V |
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| VI |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 6 |
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| Week 12 |
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| Almost Clear |
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| Marked Improvement |
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| Moderate Improvement |
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| Minimal Improvement |
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| No Change |
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| Worse |
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