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

NCT ID: NCT01448733

Last Updated: 2011-10-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-10-31

Brief 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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acanya Plus Atralin

A single, open-label arm treating acne with Cerave lotion plus Acanya gel in the morning in combination with Cerave lotion plus Atralin gel in the evening.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Acanya Gel; Atralin Gel

Eligibility 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 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zeichner, Joshua, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Joshua Zeichner

Director of Cosmetic and Clinical Research, Mt Sinai Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mt Sinai Hospital, Department of Dermatology

New York, New York, United States

Countries

United States

Other Identifiers

Coria Combo

Identifier Type: -

Identifier Source: org_study_id