check_circleStudy Completed

Perioral Dermatitis

Bayer Identifier:

1400418

ClinicalTrials.gov Identifier:

NCT00403949

EudraCT Number:

2006-002471-40

EU CT Number:

Not Available
A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

Trial purpose

The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
    - Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
    - 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
  • - History of atopic dermatitis of the face
    - Granulomatous perioral dermatitis
    - Facial acne, rosacea, facial demodicosis
    - Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
    - The use of topical or systemic medications that could affect the course of treatment and/or evaluation
    - Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
    - Use of fluorinated toothpaste
    - Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
    - Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
    - History of or suspected hypersensitivity to any ingredient of the study drugs
    - Participation in another clinical study 4 weeks prior to and/or during the conduct of this study

Trial summary

Enrollment Goal
48
Trial Dates
November 2006 - March 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Finacea (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Praxisklinik and GemeinschaftspraxisDülmen, 48249, Germany
Completed
Haut- and Geschlechtskrankheiten, Phlebologie- BerufsdermatologieRecklinghausen, 45661, Germany
Completed
HautarztpraxisBerlin, 10827, Germany

Primary Outcome

  • The sum score derived from the most important signs and symptoms of perioral dermatitis
    date_rangeTime Frame:
    Measurements and observations during the course of the study
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Intensity of single signs and symptoms
    date_rangeTime Frame:
    Measured at scheduled visits during the course of the study
    enhanced_encryption
    Safety Issue:
    No
  • Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
    date_rangeTime Frame:
    Safety parameters recorded at scheduled visits during the course of the study
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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