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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeichner, Joshua, M.D.
• Treatments: Benzoyl Peroxide; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin

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.