Study Completed

Perioral Dermatitis

Bayer Identifier:

1400418

ClinicalTrials.gov Identifier:

NCT00403949

EudraCT Number:

2006-002471-40

EU CT Number:

Not Available

A Study of Azelaic Acid (AzA) 15% in Topical Treatment of Mild to Moderate Perioral Dermatitis

Trial purpose

The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.

Key Participants Requirements

Sex

Both

Age

18 Years

Inclusion Criteria
- Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
- Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
- 8 to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)
Exclusion Criteria
- History of atopic dermatitis of the face
- Granulomatous perioral dermatitis
- Facial acne, rosacea, facial demodicosis
- Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
- The use of topical or systemic medications that could affect the course of treatment and/or evaluation
- Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
- Use of fluorinated toothpaste
- Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
- Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
- History of or suspected hypersensitivity to any ingredient of the study drugs
- Participation in another clinical study 4 weeks prior to and/or during the conduct of this study

Trial summary

Enrollment Goal

Trial Dates

November 2006 - March 2007

Phase

Phase 2

Could I Receive a placebo

Products

Finacea (Azelaic Acid, BAY39-6251)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Universitätsklinikum Essen	Essen, 45122, Germany
Completed	Praxisklinik and Gemeinschaftspraxis	Dülmen, 48249, Germany
Completed	Haut- and Geschlechtskrankheiten, Phlebologie- Berufsdermatologie	Recklinghausen, 45661, Germany
Completed	Hautarztpraxis	Berlin, 10827, Germany

Primary Outcome

The sum score derived from the most important signs and symptoms of perioral dermatitis
Time Frame:
Measurements and observations during the course of the study
Safety Issue:
No

Secondary Outcome

Intensity of single signs and symptoms
Time Frame:
Measured at scheduled visits during the course of the study
Safety Issue:
No
Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator
Time Frame:
Safety parameters recorded at scheduled visits during the course of the study
Safety Issue:
Yes

Trial design

A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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