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

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.

What this study is about