Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation

LEO Pharma240 enrolled

Overview

The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.

In an induction phase a three times weekly exposure over three weeks will be performed, followed by a resting phase. In a following challenge phase single exposure will be performed again and potential skin reactions observed. If skin reactions occur an optional re-challenge phase may be performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

240

Conditions

Healthy

Interventions

azelaic acid pre foam formulationDRUG

Vehicle pre foam formulationDRUG

WaterDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy volunteers * male or female subjects * aged 18 - 65 years * ability to understand and fulfill the study requirements Exclusion Criteria: * affected skin in designated test area * pregnancy or lactation * not willing to comply with study requirements

Locations (1)

Robert I. Cooper, MD

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

skin sensitization reaction

skin reactions will be assessed, using a standardized scoring scale

Time frame: day 3 to 6 of challenge phase week (week 6 or later, at least 2 weeks after the 3 week induction phase)

Data from ClinicalTrials.gov

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