Back to resultsSafety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Azelaic Acid Foam
Azelaic Acid Gel
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea
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
Sites / Locations
- Novum Pharmaceutical Research Services of Nevada Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Azelaic Acid Foam 15%
Azelaic Acid Gel 15%
Arm Description
Dermal application of Azelaic Acid Foam 15%
Dermal application of Azelaic Acid Gel 15%
Outcomes
Primary Outcome Measures
Baseline corrected area under the curve (AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT01257919
First Posted
December 9, 2010
Last Updated
June 8, 2023
Sponsor
LEO Pharma
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01257919
Brief Title
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azelaic Acid Foam 15%
Arm Type
Experimental
Arm Description
Dermal application of Azelaic Acid Foam 15%
Arm Title
Azelaic Acid Gel 15%
Arm Type
Active Comparator
Arm Description
Dermal application of Azelaic Acid Gel 15%
Intervention Type
Drug
Intervention Name(s)
Azelaic Acid Foam
Intervention Description
Dermal application of Azelaic Acid Foam
Intervention Type
Drug
Intervention Name(s)
Azelaic Acid Gel
Intervention Description
Dermal application of Azelaic Acid Gel
Primary Outcome Measure Information:
Title
Baseline corrected area under the curve (AUC)
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Novum Pharmaceutical Research Services of Nevada Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
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