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

Last updated: August 22, 2011
Sponsor: Zeichner, Joshua, M.D.
Overall Status: Trial Status Unknown

Phase

4

Condition

Acne

Scalp Disorders

Inflammatory Comedones

Treatment

N/A

Clinical Study ID

NCT01422785
GCO 10-1602
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females ≥ 12 years old.

  • Subjects must be in good general health as confirmed by medical history and physicalexamination.

  • Females of child-bearing potential must have a negative urine pregnancy test at thebaseline 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 (mildseverity), but no more than 4.

  • Disease must be stable or slowly worsening for more than one week prior to enteringthe 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

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 thatwould 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 vulgarisduring the study treatment.

  • Subjects who have received systemic antibiotics within 2 weeks.

  • Subjects using systemic corticosteroids or immunosuppressants within 28 days ofentering the study.

  • Subjects who have received any topical therapies for acne vulgaris within 2 weeks ofentering the study.

  • Subjects taking birth control pills for less than 3 months or solely for theprevention of acne.

  • Subjects who are currently participating in or, within the previous 28 days, haveparticipated in another study for the treatment of acne vulgaris.

  • Subjects with clinical conditions that may post a health risk to the subject by beinginvolved in the study or detrimentally affect regular follow-up of the subject.

Study Design

Total Participants: 40
Study Start date:
July 01, 2011
Estimated Completion Date:

Connect with a study center

  • Mt Sinai Hospital - Dept of Dermatology

    New York, New York 10029
    United States

    Active - Recruiting

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