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

Sponsor:	Intendis GmbH
Information provided by:	Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00403949

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.

Condition	Intervention	Phase
Perioral Dermatitis	Drug: Azelaic Acid 15% Gel Drug: Azelaic acid 15% gel Drug: Non-active base from azelaic acid 15% gel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Intendis GmbH:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intensity of single signs and symptoms [ Time Frame: Measured at scheduled visits during the course of the study ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Active Comparator: Azelaic acid 15% Gel Azelaic acid 15%	Drug: Azelaic Acid 15% Gel topical gel, apply once daily for six weeks Drug: Azelaic acid 15% gel gel, applied once daily, for 6 weeks
Placebo Comparator: 2 Non-active base from Azelaic acid 15% gel	Drug: Non-active base from azelaic acid 15% gel gel, apply once daily for six weeks

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403949

Locations

Sponsors and Collaborators

Intendis GmbH

Investigators

Study Director:

Intendis GmbH

+49 30 5200 75 802

More Information

Additional Information:

No publications provided

Responsible Party:	Klaus Graupe, Intendis GmbH
ClinicalTrials.gov Identifier:	NCT00403949 History of Changes
Other Study ID Numbers:	1400418, 2006-002471-40
Study First Received:	November 23, 2006
Last Updated:	December 3, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Dermatitis
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Azelaic acid

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012