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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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; Other Names: Acanya Gel; Atralin Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zeichner, Joshua, M.D.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ANTICIPATED): October 1, 2011
• Study Completion (ANTICIPATED): October 1, 2011

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (ESTIMATE): October 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Keratolytic Agents; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Tretinoin
• Other Study ID Numbers: Coria Combo