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Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.
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Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tazarotene Cream 0.1% | Active Comparator | 1 pea-size amount, QD x 16 weeks |
|
| Adapalene Gel 0.3% | Active Comparator | 1 pea-size amount, QD x 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazarotene Cream 0.1% | Drug | 1 pea-size amount, QD x 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremont | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tazarotene Cream 0.1% | 1 pea-size amount, QD x 16 weeks |
| FG001 | Adapalene Gel 0.3% | 1 pea-size amount, QD x 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tazarotene Cream 0.1% | 1 pea-size amount, QD x 16 weeks |
| BG001 | Adapalene Gel 0.3% | 1 pea-size amount, QD x 16 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Median Percent Change From Baseline in the Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Median percent change from baseline in the non-inflammatory lesion counts (open and closed comedones) at Week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or pimples) lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts(improvement). | Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure. | Posted | Median | Full Range | Percent Change | Baseline, Week 12 |
|
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The safety population was used to calculate the number of participants at risk for SAEs an AEs and is the total number of patients that were randomized AND treated.
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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 | Tazarotene Cream 0.1% | 1 pea-size amount, QD x 16 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold Symptoms | Infections and infestations | Non-systematic Assessment |
Study enrollment was terminated due to company decision before the target enrollment of 220 patients was reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
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| 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 |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Adapalene | Drug | 1 pea-size amount, QD x 16 weeks |
|
|
| Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne. | Week 12 |
| Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). | Baseline, Week 16 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
1 pea-size amount, QD x 16 weeks
| OG001 | Adapalene Gel 0.3% | 1 pea-size amount, QD x 16 weeks |
|
|
| Secondary | Percentage of Patients With >= 1 Grade Improvement in the Investigator Global Assessment at Week 16 | Percentage of patients with >= 1 grade improvement (decrease in score) in the Investigator Global Assessment (IGA) at Week 16. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. | Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure. | Posted | Number | Percentage of patients | Week 16 |
|
|
|
| Secondary | Percentage of Patients With >= 2 Grade Improvement in the Overall Disease Severity Score at Week 12 | Percentage of patients with >= 2 grade improvement (decrease in score) in the overall disease severity score at Week 12. The overall disease severity score was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness, and skin condition), where 0=no acne lesions and 6=most severe acne. | Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure. | Posted | Number | Percentage of patients | Week 12 |
|
|
|
| Secondary | Median Percent Change From Baseline in Inflammatory Lesion Counts (Papules/Pustules, Nodules) at Week 16 | Median percent change from baseline in inflammatory lesion counts (papules/pustules, nodules) at Week 16. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 to 10 millimeters in width and depth) and nodules are larger (greater than 5 to 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). | Intent to Treat population included all randomized patients. The number of patients that were analyzed reflects the actual number of patients for which data were available for this outcome measure. | Posted | Median | Full Range | Percent Change | Baseline, Week 16 |
|
|
|
| 0 |
| 72 |
| 10 |
| 72 |
| EG001 | Adapalene Gel 0.3% | 1 pea-size amount, QD x 16 weeks | 0 | 85 | 9 | 85 |
| Burning | General disorders | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |