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

Acne Vulgaris Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01448733
• Other study ID #: Coria Combo
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 5, 2011
• Last updated: October 6, 2011
• Start date: July 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Zeichner, Joshua, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 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.

Study Design

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening
Green pea sized amount of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning in combination with a green pea sized amount of tretinoin 0.05% gel in the evening

Locations

Country	Name	City	State
United States	Mt Sinai Hospital, Department of Dermatology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Zeichner, Joshua, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cutaneous Tolerability of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris	Evaluation of skin erythema, scaling, drying, and stinging/burning	12 weeks	Yes
Secondary	Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris	Evaluation of efficacy as defined as a global assessment of clear or almost clear after 12 weeks of therapy.	12 weeks	No