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Safety and Tolerability of Acanya Gel in Combination With Atralin Gel for Acne Vulgaris

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: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Zeichner, Joshua, M.D.


The purpose of this study is to evaluate whether Cerave lotion followed by Acanya Gel in the morning in combination with Cerave lotion followed by Atralin gel in the evening is safe and effective for the treatment of acne vulgaris.

Clinical Details

Official title: A Pilot Study to Evaluate the Safety and Tolerability of CeraVe® Lotion Followed by Fixed Dose Clindamycin Phosphate 1.2% / Benzoyl Peroxide 2.5% Gel in the Morning in Combination With CeraVe® Lotion Followed by Tretinoin 0.05% Gel in the Evening for the Treatment of Facial Acne Vulgaris.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris

Secondary outcome: Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris


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 be abstinent or use adequate birth control during the study (oral contraceptives, Norplant, Depo-Provera, or double barrier methods (e. g., condom and spermicide).

- Clear diagnosis of facial acne vulgaris for at least 6 months.

- Subject must have a static Physician's Global Assessment (PGA) of 2 (mild severity)

or 3 (moderate severity).

- 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 any ingredients in the study drugs.

- 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 7 days of

entering the study.

- Subjects taking birth control pills used solely for acne control.

- 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.

- Subjects who have Crohn's disease, colitis, or if subjects ever developed colitis or

severe diarrhea with past antibiotic use.

Locations and Contacts

Mt Sinai Hospital, Department of Dermatology, New York, New York 10029, United States
Additional Information

Starting date: July 2011
Last updated: October 6, 2011

Page last updated: August 23, 2015

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