A Study of Azelaic Acid (AzA) 15% in Topical Treatment of... | NCT00403949

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

NCT00403949

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

48Actual

Phase

Phase 2

Conditions

Perioral Dermatitis

Interventions

Azelaic acid 15% gel
Non-active base from azelaic acid 15% gel

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006-002471-40	EudraCT Number

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Nov 23, 2006

First Submission Date that Met QC Criteria

Nov 23, 2006

First Posted Date

Nov 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2023

Last Update Posted Date

Jun 9, 2023Actual

Name	Class
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azelaic acid 15% Gel	Active Comparator	Azelaic acid 15%	Drug: Azelaic acid 15% gel
Placebo	Placebo Comparator	Non-active base from Azelaic acid 15% gel	Drug: Non-active base from azelaic acid 15% gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azelaic acid 15% gel	Drug	gel, applied once daily, for 6 weeks	Azelaic acid 15% Gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The sum score derived from the most important signs and symptoms of perioral dermatitis		Measurements and observations during the course of the study

Secondary Outcomes

Measure	Description	Time Frame
Intensity of single signs and symptoms		Measured at scheduled visits during the course of the study
Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator		Safety parameters recorded at scheduled visits during the course of the study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Berlin		10827	Germany

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D005148	Facial Dermatoses

ID	Term
C010038	azelaic acid
D005782	Gels

ID	Term
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations