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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Intendis GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Intendis GmbH
ClinicalTrials.gov Identifier:
NCT01257919
First received: December 9, 2010
Last updated: April 4, 2011
Last verified: December 2010
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
U.S. FDA Resources

Further study details as provided by Intendis GmbH:

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

Estimated Enrollment: 24
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 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
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
Intendis GmbH
  More Information

Additional Information:
(Click here and search for drug information provided by the FDA)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Kaweh Shakery, Intendis GmbH
ClinicalTrials.gov Identifier: NCT01257919     History of Changes
Other Study ID Numbers: 1401843, 15386
Study First Received: December 9, 2010
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 21, 2013