Acne Vulgaris | A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Acne Vulgaris research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:clindamycin phosphate 1.2%/tretinoin 0.025% gel aloneOnce daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
Drug:clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming clothswash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
clindamycin / tretinoin gel plus benzoyl peroxide
Start Date: July 2011
Phase: Phase 4
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.
Study sponsors, principal investigator, and references
Lead Sponsor: Zeichner, Joshua, M.D.