A Study of Azelaic Acid (AzA) 15% Gel in the Treatment of... | NCT00408330

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

NCT00408330

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

48Actual

Phase

Phase 2

Conditions

Seborrheic Dermatitis on the Face

Interventions

Azelaic Acid 15% Gel
Inactive 15% gel base

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
2006-002060-26	EudraCT Number

Status Module

Record Verification Date

Mar 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

Dec 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Dec 5, 2006

First Submission Date that Met QC Criteria

Dec 5, 2006

First Posted Date

Dec 6, 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

Description Module

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

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
1	Active Comparator	azelaic acid 15%	Drug: Azelaic Acid 15% Gel
2	Placebo Comparator	Inactive 15% gel base	Drug: Inactive 15% gel base

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azelaic Acid 15% Gel	Drug	15% gel, topically applied daily for six weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Blankenfelde-Mahlow		15831	Germany

Intervention Browse Module

MeSH Terms

ID	Term
C010038	azelaic acid
D005782	Gels

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided