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

Phase 1

Completed

• Conditions: Papulopustular Rosacea
• Interventions: Drug: Azelaic Acid Foam; Drug: Azelaic Acid Gel

• Registration Number: NCT01257919
• Lead Sponsor: LEO Pharma

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 available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-02
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Azelaic Acid Foam 15%	Azelaic Acid Foam	Dermal application of Azelaic Acid Foam 15%
Azelaic Acid Gel 15%	Azelaic Acid Gel	Dermal application of Azelaic Acid Gel 15%

Primary Outcome Measures

Name	Time	Method
Baseline corrected area under the curve (AUC)	12 hours

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services of Nevada Inc.; 🇺🇸 Las Vegas, Nevada, United States