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

Primary Purpose

Seborrheic Dermatitis on the Face

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Azelaic Acid 15% Gel

Inactive 15% gel base

About this trial

This is an interventional treatment trial for Seborrheic Dermatitis on the Face

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

azelaic acid 15%

Inactive 15% gel base

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00408330

First Posted

December 5, 2006

Last Updated

June 8, 2023

Sponsor

LEO Pharma

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00408330

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seborrheic Dermatitis on the Face

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

azelaic acid 15%

Arm Title

Arm Type

Placebo Comparator

Arm Description

Inactive 15% gel base

Intervention Type

Drug

Intervention Name(s)

Azelaic Acid 15% Gel

Intervention Description

15% gel, topically applied daily for six weeks

Intervention Type

Drug

Intervention Name(s)

Inactive 15% gel base

Intervention Description

placebo, topically applied daily for six weeks

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Blankenfelde-Mahlow

ZIP/Postal Code

15831

Country

Germany

City

Buchholz

ZIP/Postal Code

21244

Country

Germany

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

City

Hamburg

ZIP/Postal Code

22049

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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