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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


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)


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Males and females ≥ 12 years old.

- Subjects must be in good general health as confirmed by medical history and physical


- 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

Page last updated: August 23, 2015

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