A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne

Zeichner, Joshua, M.D.

Status and phase

Unknown

Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths

Drug: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone

Study type

Interventional

Identifiers

NCT01422785

GCO 10-1602

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.