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

NCT ID: NCT00031096

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 879 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2002-07-31

Brief Summary

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

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.

Arm 2

Group Type: PLACEBO_COMPARATOR

Vehicle gel (SH H 655 PBA)

Intervention Type: DRUG

Vehicle gel (SH H 655 PBA) applied topically two times per day.

Interventions

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

Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.

Intervention Type: DRUG

Vehicle gel (SH H 655 PBA)

Vehicle gel (SH H 655 PBA) applied topically two times per day.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mobile, Alabama, United States

Boulder, Colorado, United States

Newnan, Georgia, United States

Shawnee Mission, Kansas, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Albuquerque, New Mexico, United States

Bay Shore, New York, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Portland, Oregon, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Bryan, Texas, United States

San Antonio, Texas, United States

Seattle, Washington, United States

Countries

United States

Other Identifiers

304343 (90905)

Identifier Type: OTHER

Identifier Source: secondary_id

306100 (91138)

Identifier Type: OTHER

Identifier Source: secondary_id

4343

Identifier Type: OTHER

Identifier Source: secondary_id

90905

Identifier Type: -

Identifier Source: org_study_id