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

NCT ID: NCT00408330

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Seborrheic Dermatitis on the Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

azelaic acid 15%

Group Type ACTIVE_COMPARATOR

Azelaic Acid 15% Gel

Intervention Type DRUG

15% gel, topically applied daily for six weeks

2

Inactive 15% gel base

Group Type PLACEBO_COMPARATOR

Inactive 15% gel base

Intervention Type DRUG

placebo, topically applied daily for six weeks

Interventions

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Azelaic Acid 15% Gel

15% gel, topically applied daily for six weeks

Intervention Type DRUG

Inactive 15% gel base

placebo, topically applied daily for six weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Blankenfelde-Mahlow, , Germany

Site Status

Buchholz, , Germany

Site Status

Hamburg, , Germany

Site Status

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2006-002060-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1401201

Identifier Type: -

Identifier Source: org_study_id

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