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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00408330

Enrollment

Registered

2006-12-06

Start date

2006-12-31

Completion date

2007-03-31

Last updated

2023-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Dermatitis on the Face

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

Interventions

DRUGAzelaic Acid 15% Gel

15% gel, topically applied daily for six weeks

DRUGInactive 15% gel base

placebo, topically applied daily for six weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.	Measurement of parameters during the course of treatment (six weeks)

Secondary

Measure	Time frame
Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms	Measurement of parameters during the course of treatment (six weeks)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026