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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00031096
Recruitment Status : Completed
First Posted : February 22, 2002
Last Update Posted : April 1, 2020
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE February 21, 2002
First Posted Date  ICMJE February 22, 2002
Last Update Posted Date April 1, 2020
Study Start Date  ICMJE January 2002
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2009)
  • Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability [ Time Frame: 12 weeks ]
  • Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
    Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
  • Drug: Vehicle gel (SH H 655 PBA)
    Vehicle gel (SH H 655 PBA) applied topically two times per day.
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Vehicle gel (SH H 655 PBA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2009)
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
Actual Study Completion Date  ICMJE July 2002
Actual Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00031096
Other Study ID Numbers  ICMJE 90905
304343 (90905) ( Other Identifier: Company internal )
306100 (91138) ( Other Identifier: Company internal )
4343 ( Other Identifier: Company internal )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account LEO Pharma
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP