check_circleStudy Completed

Seborrheic Dermatitis on the Face

Bayer Identifier:

1401201

ClinicalTrials.gov Identifier:

NCT00408330

EudraCT Number:

2006-002060-26

EU CT Number:

Not Available
A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of Seborrheic Dermatitis of the Face

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Stable or exacerbating seborrheic dermatitis in the facial area
  • - 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

Trial summary

Enrollment Goal
48
Trial Dates
December 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
SCIderm Scientific ResearchHamburg, 20354, Germany
Completed
Private PracticeBuchholz, 21244, Germany
Completed
Private PracticeBlankenfelde-Mahlow, 15831, Germany
Completed
Private PracticeHamburg, 22049, Germany

Primary Outcome

  • Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
    date_rangeTime Frame:
    Measurement of parameters during the course of treatment (six weeks)
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    Safety Issue:
    No

Secondary Outcome

  • Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms
    date_rangeTime Frame:
    Measurement of parameters during the course of treatment (six weeks)
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    Safety Issue:
    No

Trial design

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
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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