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

• Sponsor: LEO Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01257919
• Collaborator: Bayer (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 1.9
• Patients Per Site Per Month: 10.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: Azelaic Acid Foam; Drug: Azelaic Acid Gel	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Baseline corrected area under the curve (AUC) [12 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novum Pharmaceutical Research Services of Nevada Inc.	Las Vegas	Nevada	United States	89121

Sponsors and Collaborators

• LEO Pharma
• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01257919
• Other Study ID Numbers: 15386; 1401843
• First Posted: Dec 10, 2010
• Last Update Posted: Apr 1, 2020
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Rosacea; Azelaic acid

Study Results

No Results Posted as of Apr 1, 2020