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NCT Number: NCT00408330

A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face

This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.

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Key information

Conditions

Seborrheic Dermatitis on the Face

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Blankenfelde-Mahlow, Germany

Loading trial locations.

About this study

To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable or exacerbating seborrheic dermatitis in the facial area

Exclusion criteria

  • Psoriasis
  • Atopic dermatitis
  • Facial acne and rosacea
  • Dermatophytic skin infections
  • Parkinson's disease
  • Known immunosuppression; HIV infection
  • Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
  • Continuous asthma inhalation treatment requiring > 800 mg corticosteroids
  • Any severe disease likely to interfere with the conduct or the planned termination of the study

Treatment and study plan

Azelaic acid 15% Gel

Drug

15% gel, topically applied daily for six weeks

Inactive 15% gel base

Drug

placebo, topically applied daily for six weeks

Primary outcomes

  1. Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.

    Time frame: Measurement of parameters during the course of treatment (six weeks)

Secondary outcomes

  1. Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms

    Time frame: Measurement of parameters during the course of treatment (six weeks)

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Official study title

A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 6, 2006
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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