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

June 8, 2023 updated by: LEO Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Blankenfelde-Mahlow, Germany, 15831
      • Buchholz, Germany, 21244
      • Hamburg, Germany, 20354
      • Hamburg, Germany, 22049

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
azelaic acid 15%
Drug: Azelaic Acid 15% Gel
15% gel, topically applied daily for six weeks
Placebo Comparator: 2
Inactive 15% gel base
Drug: Inactive 15% gel base
placebo, topically applied daily for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Measurement of parameters during the course of treatment (six weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Measurement of parameters during the course of treatment (six weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

December 5, 2006

First Submitted That Met QC Criteria

December 5, 2006

First Posted (Estimated)

December 6, 2006

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401201
  • 2006-002060-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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