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The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the treatment of acne vulgaris.
The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for mild to moderate acne vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzoyl Peroxide | Active Comparator | Benzoyl Peroxide (BP) 2.5% |
|
| Benzoyl Peroxide plus moisturizing lotion | Active Comparator | Benzyol Peroxide 2.5% plus moisturizing lotion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzoyl Peroxide | Drug | Benzoyl Peroxide 2.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Change From Baseline Scale | -1=worse 0=unchanged
| baseline and 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Department of Dermatology | Chicago | Illinois | 60611 | United States |
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Participants in this study were patients clinically diagnosed with acne vulgaris. Participants will be recruited from the clinic. Patients were 18 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects | Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects | Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face. |
| 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 |
| 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 | Subject Reported Change From Baseline Scale | -1=worse 0=unchanged
| Posted | Number | Participants | baseline and 1 month |
|
|
1 month
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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 | Benzoyl Peroxide 2.5% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dryness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Paller, MD | Northwestern University | 312-695-6829 | apaller@nmff.org |
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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 |
|---|---|
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Moisturizing Lotion | Drug |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | Benzoyl Peroxide 2.5% Plus Moisturizing Lotion | 0 | 11 | 6 | 11 |
| Burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |