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This study is a split face, paired-comparison, pilot study of 10 subjects. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from the clinic, as well as advertising and from previous Institutional Review Board (IRB) approved acne studies housed in the Department of Dermatology. All subjects accrued from previous studies have agreed to be contacted for further investigations. Subjects 13 to 35 years of age with mild to moderate acne vulgaris symmetrical in appearance on both sides of the face, and meeting inclusion criteria will be eligible to participate.
Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface, carrying along with it desquamated cells from follicular epithelium. Acne develops when these specialized follicles undergo pathologic alterations that result in the formation of non-inflammatory lesions (comedones) and inflammatory lesions (papules, pustules, and nodules).
The basic cause of acne remains unknown, but its manifestations are thought to be the product of four pathogenic events: 1) increased sebum production fueled by androgenic stimulation in the pubertal period; 2) obstruction of the pilosebaceous unit due to an abnormal keratinization process; 3) proliferation of Propionibacterium acnes, an anaerobic diptheroid normally residing in pilosebaceous follicles; and 4) inflammation that is mediated both by the action of chemotactic factors and various enzymes, and initiated in part by the interaction of P. acnes with toll-like receptors. Impaction of the pilosebaceous follicle gives rise to the microcomedo that is thought to be the precursor lesion of acne.
Topical benzoyl peroxide is a common and well-established agent with known antibacterial and antimicrobial properties used in the treatment of acne vulgaris. The safety profile for topical benzoyl peroxide has been well delineated. The most common side effects attributed to benzoyl peroxide products include irritation, dryness, scaling, burning and stinging.
Benzoyl peroxide 10.0% creams (Formulation #1 and Formulation #2) will be evaluated to detect any differences in their response for safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left side of face | Experimental | Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to left side of the face. |
|
| Right side of face | Experimental | Topical benzoyl peroxide 10.0% cream - Formulation 2 or Topical benzoyl peroxide 10.0% cream - Formulation 1 is to be applied to right side of the face. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical benzoyl peroxide 10.0% cream - Formulation 1 | Drug | Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Inflammatory Lesions (Papules and Pustules) | Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2. | 4 Weeks |
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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 |
|---|---|---|---|---|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
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Participants were recruited from the clinic, as well as advertising in the Department of Dermatology.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Apply Formula #1 to assigned side of face twice daily. Apply Formula #2 to assigned side of face twice daily. |
| 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 | Number of Inflammatory Lesions (Papules and Pustules) | Assessment will be done based on lesion counting. We will compare the lesions treated twice daily with the benzoyl peroxide 10.0% cream Formulation #1 vs. the benzoyl peroxide 10.0% cream Formulation #2. | Papules and pustules were analyzed on the left and right side of the face for each of the 10 subjects. Analysis was per protocol with intention to treat. | Posted | Number | Lesions | 4 Weeks |
|
4 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 | Benzoyl Peroxide 10.0% Cream Formulation #1 | Formulation #1 applied to one side of the face by all 10 subjects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burning/Stinging | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Paller, MD | Northwestern University | 312-695-3721 | apaller@northwestern.edu |
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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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|
| Topical benzoyl peroxide 10.0% cream - Formulation 2 | Drug | Formulation 1 will be applied to the randomly-assigned single (left or right) side of the face twice daily. |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible. |
| OG002 | Papules: Benzoyl Peroxide 10.0% Cream Formulation #2 | Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible. |
| OG003 | Pustules: Benzoyl Peroxide 10.0% Cream Formulation #2 | Apply a pea size amount two times a day, in the morning and evening. Smooth evenly into skin until it becomes invisible. |
|
|
| 0 |
| 10 |
| 8 |
| 10 |
| EG001 | Benzoyl Peroxide 10.0% Cream: Formulation #2 | Formulation #2 applied to one side of the face by all 10 subjects. | 0 | 10 | 8 | 10 |
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |