Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2009-11-30
2010-04-30
Brief Summary
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Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
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Detailed Description
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inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Photo skin types IV - VI
* Ages 12 and older
* Both sexes
* Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
* Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives
Exclusion Criteria
* PIH of solely dermal origin
* Acne vulfaris known to be resistant to oral antibiotics
* Use of erythromycin-containing products
* Use of neuromuscular blocking agents
* Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).
12 Years
ALL
No
Sponsors
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Society Hill Dermatology
OTHER
Callender Center for Clinical Research
OTHER
Responsible Party
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Callender Center for Clinical Research
Principal Investigators
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Valerie Callender, MD
Role: PRINCIPAL_INVESTIGATOR
Callender Center for Clinical Research
Locations
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Callender Center for Clinical Research
Mitchellville, Maryland, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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VDC2009Z
Identifier Type: -
Identifier Source: org_study_id
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