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

NCT01448733 | Unknown Phase 4 DMC

• 1 other identifier: Coria Combo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

acne vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficacy of Combination Therapy of Acanya Gel with Atralin Gel for the treatment of acne vulgaris

  12 weeks

Study Arms (1)

Acanya Plus Atralin

EXPERIMENTAL

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

Interventions

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

Also known as: Acanya Gel, Atralin Gel

Acanya Plus Atralin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeichner, Joshua, M.D.: lead

Study Sites (1)

Mt Sinai Hospital, Department of Dermatology

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl Peroxide; clindamycin phosphate; Gels; Acanya Gel; Atralin Gel

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cosmetic and Clinical Research, Mt Sinai Dermatology

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 7, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 7, 2011

Record last verified: 2011-10

Locations

US (1)