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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01257919

First received: December 9, 2010

Last updated: February 19, 2014

Last verified: February 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Papulopustular Rosacea	Drug: Azelaic Acid Foam Drug: Azelaic Acid Gel	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Azelaic acid

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Baseline corrected area under the curve (AUC) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]


Enrollment:	21
Study Start Date:	January 2011
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Azelaic Acid Foam 15% Dermal application of Azelaic Acid Foam 15%	Drug: Azelaic Acid Foam Dermal application of Azelaic Acid Foam
Active Comparator: Azelaic Acid Gel 15% Dermal application of Azelaic Acid Gel 15%	Drug: Azelaic Acid Gel Dermal application of Azelaic Acid Gel

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257919

Locations


United States, Nevada
Novum Pharmaceutical Research Services of Nevada Inc.
Las Vegas, Nevada, United States, 89121

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01257919 History of Changes
Other Study ID Numbers:	15386, 1401843
Study First Received:	December 9, 2010
Last Updated:	February 19, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Rosacea Skin Diseases Azelaic acid Antineoplastic Agents	Dermatologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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