Status:
UNKNOWN
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Lead Sponsor:
Zeichner, Joshua, M.D.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
There are many different factors that cause acne. So combination treatment using different medications that can address these different factors is commonly used to treat acne. Fixed-dose combination c...
Eligibility Criteria
Inclusion
- Males and females ≥ 12 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
- Clear diagnosis of facial acne vulgaris for at least 3 months.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
- Disease must be stable or slowly worsening for more than one week prior to entering the study.
- Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
Exclusion
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with very severe acne (PGA score of 5)
- Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
- Subjects with a current active skin malignancy or infection.
- Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
- Subjects who have received systemic antibiotics within 2 weeks.
- Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
- Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
- Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
- Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01422785
Start Date
July 1 2011
Last Update
August 24 2011
Active Locations (1)
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1
Mt Sinai Hospital - Dept of Dermatology
New York, New York, United States, 10029