Trial Condition(s):

Acne vulgaris

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

Bayer Identifier:

90905

ClinicalTrials.gov Identifier:

NCT00031096

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
879
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dermatology Clinical Research Center

San Antonio, United States, 78229

Status
Completed
 
Locations

Central Kentucky Research Associates, Inc.

Lexington, United States, 40509

Status
Completed
 
Locations

PMG Research of Winston-Salem, Inc.

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Boulder Medical Center

Boulder, United States, 80304

Status
Completed
 
Locations

J & S Studies, Inc.

Byran, United States, 77802

Status
Completed
 
Locations

Seattle Women's: Health, Research, Gynecology

Seattle, United States, 98105

Status
Completed
 
Locations

Meda Phase Inc.

Newnan, United States, 30263

Status
Completed
 
Locations

Dermatology Research Associates, Inc.

Cincinnati, United States, 45230

Status
Completed
 
Locations

Oregon Medical Research Center

Portland, United States, 97223-6683

Status
Completed
 
Locations

Compliant Clinical Research, Inc.

Wichita, United States, 67206

Status
Completed
 
Locations

Coastal Clinical Research, Inc

Mobile, United States, 36608

Status
Completed
 
Locations

Medical & Clinical Research Associates

Bayshore, United States, 11706

Status
Completed
 
Locations

Compliant Clinical Research, Inc.

Shawnee, United States, 66203

Status
Completed
 
Locations

Dermatology Associates of Knoxville

Knoxville, United States, 37922

Status
Completed
 
Locations

Pennsylvania State University College of Medicine

Hershey, United States, 17033

Status
Completed
 
Locations

Academic Dermatology Associates

Albuquerque, United States, 87106

Status
Completed
 

Trial Design