Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne

Study Overview
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Brief Summary
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Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne. Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.

Detailed Description
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Acne is a common inflammatory skin condition characterized by skin eruptions around hair follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders, but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the safety and effectiveness of an investigational gel containing active medication compared to the same gel without any active medication (placebo or vehicle) in subjects with mild to moderate facial acne. This study has initially been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Intendis Inc., a Bayer HealthCare company, is the sponsor of the trial.

Official Title
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A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
* Drug: Vehicle gel (SH H 655 PBA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in the study you MUST have: Predominantly facial localization of acne Mild to moderate acne vulgaris characterized by the presence of both inflammatory papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity suitable for treatment with topical single therapy. a minimum of ten and a maximum of fifty inflammatory papules and/or pustules in the facial area and 10 to 100 comedones in the facial area no more than 3 small nodules (approx. 5 mm in diameter) in the facial area Male and female patients Age greater or equal to 12 years Ability and willingness to accept and comply with the administration of the investigational drugs over 12 weeks and to comply with the required medical examinations (signed informed consent). Exclusion Criteria: To be included in the study you MUST NOT have: Localization of acne predominantly on the chest and/or the back or confined to the chest and/or the back Sandpaper acne with hundreds of small facial comedones Moderate or severe acne requiring systemic therapy Multitude of small nodules and/or multiple large nodules, cysts, polyporous comedones, draining sinuses e.g. nodulocystic/conglobate acne Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulopustular rosacea) Anticipated or scheduled hospitalization, e.g. for surgery, during the study Female patients who have not continuously used their present brand of oral contraceptive (if any) or other hormone therapy for at least 3 months Continuous concurrent use of any topical and/or systemic treatment which affects acne History of hypersensitivity to any ingredient of the trial drugs Concurrent involvement in another investigational study or participation within 30 days prior to the start of this study You must not have taken or have had the following types of treatment or therapy prior to being admitted into the study: Oral isotretinoin (i.e. Accutane) for 6 months Ortho Tri-Cyclen or Estrostep for 3 months Oral antibiotics (i.e. tetracyclines, erythromycin) for 4 weeks Systemic corticosteroids for 4 weeks Systemic non-steroidal anti-inflammatory drugs (NSAIDs) at anti-inflammatory doses for 4 weeks Topical (applied to skin) retinoid creams, ointments, gels for 2 weeks Topical antibiotics (i.e. tetracyclines, erythromycin, clindamycin) for 2 weeks Topical corticosteroids or topical non-steroidal anti-inflammatory (NSAIDs) drugs for 2 weeks Topical imidazole antimycotics for 2 weeks Topical benzoyl peroxide (BPO) for 2 weeks Topical over-the-counter remedies for acne (salicylic acid) for 2 weeks If you have had any of the above, you may still qualify for the study following a washout period (time for your body to completely eliminate, or get rid of, the medication). The study doctor will evaluate whether there is anything else in your history that may affect your safety in the study or interfere with evaluations. He/she may therefore advise you not to participate.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)<br>* Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.<br>|
| Placebo Comparator: Arm 2<br> | Drug: Vehicle gel (SH H 655 PBA)<br>* Vehicle gel (SH H 655 PBA) applied topically two times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability |  | 12 weeks | 
| Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Propionibacterium acnes