A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Information source: Zeichner, Joshua, M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone (Drug); clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Zeichner, Joshua, M.D. Overall contact: Vicky Wong, Phone: 212-241-3288
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 clindamycin phosphate 1. 2% and tretinoin 0. 025% gel and benzoyl
peroxide 6% foaming cloths are both used to treat acne. This study will evaluate the use of
the medications when used together.
Clinical Details
Official title: A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
Secondary outcome: Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.Total number of adverse events. Change in Subject Self Assessment Scoring Scale Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Vicky Wong, Phone: 212-241-3288
Mt Sinai Hospital - Dept of Dermatology, New York, New York 10029, United States; Recruiting Vicky Wong, Phone: 212-241-3288 Joshua Zeichner, MD, Principal Investigator
Additional Information
Starting date: July 2011
Last updated: August 22, 2011
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