Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01257919
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
LEO Pharma

Tracking Information
First Submitted Date  ICMJE December 9, 2010
First Posted Date  ICMJE December 10, 2010
Last Update Posted Date April 1, 2020
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2010)
Baseline corrected area under the curve (AUC) [ Time Frame: 12 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Papulopustular Rosacea
Intervention  ICMJE
  • Drug: Azelaic Acid Foam
    Dermal application of Azelaic Acid Foam
  • Drug: Azelaic Acid Gel
    Dermal application of Azelaic Acid Gel
Study Arms  ICMJE
  • Experimental: Azelaic Acid Foam 15%
    Dermal application of Azelaic Acid Foam 15%
    Intervention: Drug: Azelaic Acid Foam
  • Active Comparator: Azelaic Acid Gel 15%
    Dermal application of Azelaic Acid Gel 15%
    Intervention: Drug: Azelaic Acid Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2013)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2010)
24
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257919
Other Study ID Numbers  ICMJE 15386
1401843 ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Bayer
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account LEO Pharma
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP