Novel Topical Treatment for Disorders of Keratinization

角化疾病的新型局部治疗

• 批准号: 6883343
• 负责人: BAKUL M BHATT
• 金额: $ 12.83万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-15 至 2007-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883343
• 关键词: biomaterial development /preparation; clinical research; clinical trials; copolymer; drug screening /evaluation; drug vehicle; high performance liquid chromatography; human subject; human therapy evaluation; keratinization; pharmacokinetics; polyvinyls; salicylate; skin absorption; skin disorder; skin disorder chemotherapy; skin irritation /irritant; skin pharmacology; surface coating; topical drug application; transdermal drug delivery; urea

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.

描述（由申请人提供）：角质化障碍是一组异质性疾病，其特征在于干燥和鳞状皮肤，其表现出角质层生物物理性质的变化，特别是关于水渗透屏障。这些疾病，也称为角化病症，包括各种形式的鱼鳞病、掌跖角化病和毛囊角化病，如达里尔病和毛发角化病。毛发角化病在40%的人口中普遍存在，并且在青少年女性中高达80%。目前的治疗选择包括使用润肤剂和保湿剂，以及角质层分离剂，包括水杨酸、尿素或α-羟基酸。该项目的目标是评估专利的聚合物涂层技术作为一种新型的局部治疗角质化疾病。为了证明涂层的可行性和有效性，将追求以下具体目标：目标1。制定涂料用于治疗疾病的角化。将优化包衣制剂以提供适用于治疗角化病症的包衣。将角质层溶解剂掺入涂层中，以研究与制剂的相容性。目标二。在人体临床试验中证明涂层的有效性。该测定将证明皮肤涂层在治疗角化病症中的有效性。将在皮肤涂层和含有角质层溶解剂的皮肤涂层之间进行双盲、右/左比较。