Novel Topical Treatment for Disorders of Keratinization

DESCRIPTION (provided by applicant): Disorders of keratinization are a heterogeneous group of diseases characterized by dry and scaly skin that demonstrate changes in the biophysical properties of the stratum corneum, especially with respect to the water permeability barrier. These diseases, also known as disorders of cornification, include various forms of ichthyosis, palmoplantar keratoderma, and follicular keratoses such as Darier's disease and keratosis pilaris. Keratosis pilaris is prevalent in 40% of the population, and as high as 80% of adolescent women. Current treatment options include the use of emollients and moisturizers, and keratolytic agents including salicylic acid, urea, or alpha hydroxy acids. The goal of this project is to evaluate a patented polymer-based coating technology as a novel topical treatment for disorders of keratinization. In order to demonstrate feasibility and effectiveness of the coatings, the following Specific Aims will be pursued: Aim 1. Formulate Coatings for the Treatment of Diseases of Keratinization. The coating formulation will be optimized to provide coatings suitable for use in the treatment of disorders of keratinization. Keratolytic agents will be incorporated into coatings to investigate compatibility with the formulation. Aim 2. Demonstrate Efficacy of Coatings in a Human Clinical Trial. This assay will demonstrate the effectiveness of skin coatings in treating a disorder of keratinization. A double-blind, right/left comparison will be made between the skin coating and the skin coating containing a keratolytic agent.