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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00031096
First received: February 21, 2002
Last updated: February 23, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Acne Vulgaris
Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
Drug: Vehicle gel (SH H 655 PBA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 879
Study Start Date: January 2002
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
Placebo Comparator: Arm 2 Drug: Vehicle gel (SH H 655 PBA)
Vehicle gel (SH H 655 PBA) applied topically two times per day.

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031096

Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Colorado
Boulder, Colorado, United States, 80304
United States, Georgia
Newnan, Georgia, United States, 30263
United States, Kansas
Shawnee, Kansas, United States, 66203
Wichita, Kansas, United States, 67206
United States, Kentucky
Lexington, Kentucky, United States, 40509
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Bayshore, New York, United States, 11706
United States, North Carolina
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45230
United States, Oregon
Portland, Oregon, United States, 97223-6683
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Knoxville, Tennessee, United States, 37922
United States, Texas
Byran, Texas, United States, 77802
San Antonio, Texas, United States, 78229
United States, Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00031096     History of Changes
Other Study ID Numbers: 90905, 304343 (90905), 306100 (91138), 4343
Study First Received: February 21, 2002
Last Updated: February 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Acne Vulgaris
Propionibacterium acnes

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Azelaic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 11, 2014