A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

Last updated: June 8, 2023
Sponsor: LEO Pharma
Overall Status: Completed

Phase

2

Condition

Dermatitis, Atopic

Scalp Disorders

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Azelaic acid 15% gel

Non-active base from azelaic acid 15% gel

Clinical Study ID

NCT00403949
1400418
2006-002471-40
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by thephysician
  • Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to
  • 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)

Exclusion

Exclusion Criteria:

  • 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 treatmentand/or evaluation
  • Severe diseases likely to interfere with the conduct / planned termination of thestudy (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 areathroughout the course of the study
  • Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fattylipstick) 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 ofthis study

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Azelaic acid 15% gel
Phase: 2
Study Start date:
November 01, 2006
Estimated Completion Date:
March 31, 2007

Connect with a study center

  • Berlin, 10827
    Germany

    Site Not Available

  • Dülmen, 48249
    Germany

    Site Not Available

  • Essen, 45122
    Germany

    Site Not Available

  • Recklinghausen, 45661
    Germany

    Site Not Available

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