Actinic Keratosis Clinical Trial
Official title:
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of LEO 43204 Gel and Gel Vehicle in Healthy Volunteers Using a Repeat Insult Patch Test Design
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.
n/a
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