Clinical trial NCT00031096: Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Propionibacterium acnes
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2002-02-22
Enrollment: 879
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigators rating of overall improvement and patients self assessment of overall improvement and cosmetic acceptability
timeFrame: 12 weeks
measure: Adverse event reports and patient's opinion on local tolerability of the study gels at the end of study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Boulder
country: United States
state: Colorado
city: Newnan
country: United States
state: Georgia
city: Shawnee Mission
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Albuquerque
country: United States
state: New Mexico
city: Bay Shore
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Bryan
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: