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

Primary Purpose

Perioral Dermatitis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Azelaic acid 15% gel

Non-active base from azelaic acid 15% gel

About this trial

This is an interventional treatment trial for Perioral Dermatitis

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Azelaic acid 15% Gel

Placebo

Arm Description

Azelaic acid 15%

Non-active base from Azelaic acid 15% gel

Outcomes

Primary Outcome Measures

The sum score derived from the most important signs and symptoms of perioral dermatitis

Secondary Outcome Measures

Intensity of single signs and symptoms

Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator

Full Information

NCT ID

NCT00403949

First Posted

November 23, 2006

Last Updated

June 8, 2023

Sponsor

LEO Pharma

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00403949

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

November 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

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.

6. Conditions and Keywords

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

Perioral Dermatitis

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

Azelaic acid 15% Gel

Arm Type

Active Comparator

Arm Description

Azelaic acid 15%

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Non-active base from Azelaic acid 15% gel

Intervention Type

Drug

Intervention Name(s)

Azelaic acid 15% gel

Intervention Description

gel, applied once daily, for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Non-active base from azelaic acid 15% gel

Intervention Description

gel, apply once daily for six weeks

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Intensity of single signs and symptoms

Time Frame

Measured at scheduled visits during the course of the study

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Berlin

ZIP/Postal Code

10827

Country

Germany

City

Dülmen

ZIP/Postal Code

48249

Country

Germany

City

Essen

ZIP/Postal Code

45122

Country

Germany

City

Recklinghausen

ZIP/Postal Code

45661

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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