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

LEO Pharma

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)

Drug: Vehicle gel (SH H 655 PBA)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00031096

304343 (90905) (Other Identifier)

306100 (91138) (Other Identifier)

4343

90905

Details and patient eligibility

About

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.

Full description

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.

Enrollment

879 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.