Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in... | NCT01257919

Studies
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea

NCT01257919

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Jun 9, 2023Actual

Enrollment

21Actual

Phase

Phase 1

Conditions

Papulopustular Rosacea

Interventions

Azelaic Acid Foam
Azelaic Acid Gel

Countries

United States

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
1401843	Other Identifier	Company Internal

Status Module

Record Verification Date

Feb 2014

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

Jan 2011

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 9, 2010

First Submission Date that Met QC Criteria

Dec 9, 2010

First Posted Date

Dec 10, 2010Estimated

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

Assessment of pharmacokinetics of Azelaic Acid Foam after repeated skin application and in comparison to Azelaic Acid gel.

Assessment of safety after repeated skin application.

Detailed Description

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azelaic Acid Foam 15%	Experimental	Dermal application of Azelaic Acid Foam 15%	Drug: Azelaic Acid Foam
Azelaic Acid Gel 15%	Active Comparator	Dermal application of Azelaic Acid Gel 15%	Drug: Azelaic Acid Gel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azelaic Acid Foam	Drug	Dermal application of Azelaic Acid Foam	Azelaic Acid Foam 15%

Measure	Description	Time Frame
Baseline corrected area under the curve (AUC)		12 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of moderate papulopustular rosacea
free of any clinically significant disease

Exclusion Criteria:

body weight less than 50 or more than 130 kg
clinically significant disease which could interfere with 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
Novum Pharmaceutical Research Services of Nevada Inc.		Las Vegas	Nevada	89121	United States

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided