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

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LEO Pharma

Status and phase

Completed
Phase 2

Conditions

Perioral Dermatitis

Treatments

Drug: Azelaic acid 15% gel
Drug: Non-active base from azelaic acid 15% gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00403949
1400418
2006-002471-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

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 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups, including a placebo group

Azelaic acid 15% Gel
Active Comparator group
Description:
Azelaic acid 15%
Treatment:
Drug: Azelaic acid 15% gel
Placebo
Placebo Comparator group
Description:
Non-active base from Azelaic acid 15% gel
Treatment:
Drug: Non-active base from azelaic acid 15% gel

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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