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

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.

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251); Drug: Vehicle gel (SH H 655 PBA)

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.

• Study Type: Interventional
• Enrollment (Actual): 879
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
  • Colorado
    • Boulder, Colorado, United States, 80304
  • Georgia
    • Newnan, Georgia, United States, 30263
  • Kansas
    • Shawnee Mission, Kansas, United States, 66203
    • Wichita, Kansas, United States, 67206
  • Kentucky
    • Lexington, Kentucky, United States, 40509
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • New York
    • Bay Shore, New York, United States, 11706
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Cincinnati, Ohio, United States, 45230
  • Oregon
    • Portland, Oregon, United States, 97223-6683
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
  • Texas
    • Bryan, Texas, United States, 77802
    • San Antonio, Texas, United States, 78229
  • Washington
    • Seattle, Washington, United States, 98105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability	12 weeks
Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study	12 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): July 1, 2002
• Study Completion (Actual): July 1, 2002

Study Registration Dates

• First Submitted: February 21, 2002
• First Submitted That Met QC Criteria: February 21, 2002
• First Posted (Estimated): February 22, 2002

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Propionibacterium acnes; Acne Vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 90905; 304343 (90905) (Other Identifier: Company internal); 306100 (91138) (Other Identifier: Company internal); 4343 (Company internal)