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

LEO Pharma21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Papulopustular Rosacea

Interventions

Azelaic Acid FoamDRUG

Dermal application of Azelaic Acid Foam

Azelaic Acid GelDRUG

Dermal application of Azelaic Acid Gel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novum Pharmaceutical Research Services of Nevada Inc.

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Baseline corrected area under the curve (AUC)

Time frame: 12 hours

Data from ClinicalTrials.gov

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