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A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel

2016-01-11 12:05:26 | BioPortfolio

Summary

This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers.

LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation.

Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization.

A total of 10 applications will be made over a period of approximately 6-8 weeks.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Conditions

Actinic Keratosis

Intervention

LEO 43204, LEO 43204 Vehicle

Location

TKL Research Inc.
Fair Lawn
New Jersey
United States
07410

Status

Not yet recruiting

Source

LEO Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-01-11T12:05:26-0500

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