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

NCT00031096 | Completed Phase 3

• 4 other identifiers: 90905304343 (90905)306100 (91138)4343
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 16

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.

Conditions

Acne Vulgaris

Keywords

Acne Vulgaris; Propionibacterium acnes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Arm 2

PLACEBO COMPARATOR

Drug: Vehicle gel (SH H 655 PBA)

Interventions

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

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

Arm 1

Vehicle gel (SH H 655 PBA) DRUG

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

Arm 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead
• Bayer: collaborator

Study Sites (16)

Unknown Facility

Mobile, Alabama, 36608, United States

Location

Unknown Facility

Boulder, Colorado, 80304, United States

Location

Unknown Facility

Newnan, Georgia, 30263, United States

Location

Unknown Facility

Shawnee Mission, Kansas, 66203, United States

Location

Unknown Facility

Wichita, Kansas, 67206, United States

Location

Unknown Facility

Lexington, Kentucky, 40509, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Bay Shore, New York, 11706, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45230, United States

Location

Unknown Facility

Portland, Oregon, 97223-6683, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Knoxville, Tennessee, 37922, United States

Location

Unknown Facility

Bryan, Texas, 77802, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2002
• First Posted: February 22, 2002
• Study Start: January 1, 2002
• Primary Completion: July 1, 2002
• Study Completion: July 1, 2002
• Last Updated: June 9, 2023

Record last verified: 2014-02

Locations

US (16)