Furthering the clinical development of a first in class, water resistant sunscreen to meet emerging environmental regulations

推进一流防水防晒霜的临床开发，以满足新兴的环境法规

• 批准号: 10255409
• 负责人: Steven Isaacman
• 金额: $ 39.88万
• 依托单位: NANOMETICS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255409
• 关键词: Address; Affinity; American; Bathing; Biological Sciences; Biomass; Carbon; Chemistry; Cream; Cutaneous; Development; Diagnosis; Ecosystem; Elastomers; Esthetics; Europe; Excipients; Excision; Florida; Goals; Healthcare; Home; Human; Immersion; Incidence; International; Knowledge; Label; Link; Malignant Neoplasms; Manufacturer Name; Market Research; Mediating; Mission; Modeling; National Cancer Institute; Outcome; Performance; Phase; Phototoxicity; Plants; Preventive measure; Process; Property; Regulation; Research Support; Resistance; Risk; Risk Factors; Safety; Sales; Silicone Elastomers; Skin; Skin Cancer; Small Business Innovation Research Grant; Statutes and Laws; Sun protection factor; Sunlight; Sunscreening Agents; Swimming; Technology; Time; Toxic effect; Tube; UV Radiation Exposure; UV protection; Ultraviolet Rays; United States; United States Food and Drug Administration; Water; base; biodegradable polymer; biomaterial compatibility; cancer care; clinical development; commercial application; consumer demand; design; falls; global environment; healthy volunteer; improved; novel; photoprotection; prevent; sensor; skin organogenesis; success; technological innovation; ultraviolet damage; volunteer

PROJECT SUMMARY / ABSTRACT Problem to be Solved and Significance: Exposure to Ultraviolet radiation (UVR) is a risk factor for the development of skin cancer, and health care agencies recommend that sunscreens be used as a preventative measure. Recent legislation in the U.S. and internationally has banned the sale of ingredients that are fundamental to water-resistant sunscreens, creating an urgent need for new products that satisfy existing and emerging legislation. Product and Long-Term Goal: The product of this SBIR will be a wholly biocompatible SPF 30 broad spectrum sunscreen cream, sold in 6-oz tubes, that satisfies FDA’s criteria to be labeled as ‘Water Resistant (80 min)’ and is based on the Nanometics (d.b.a. PHD Biosciences [PHD]) proprietary elastomer technology. Successful development of this sunscreen product directly addresses the mission of the National Cancer Institute by improving protection against UVR and decreasing the risk of skin cancer. Technological Innovation: The PHD sunscreen incorporates PHD’s proprietary biodegradable elastomer technology, which is the first plant derived elastomer for topical products that provides water resistance, is compatible with all Food and Drug Administration approved UV filters, and recapitulates the favorable aesthetic properties of silicone elastomers. Specific Aim #1. To demonstrate that the PHD Sunscreen is water resistant for at least 80 min on healthy volunteers. Studies in this Aim will be conducted under FDA guidance and will demonstrate the feasibility that the PHD sunscreen is resistant to removal with water after 80 min of continuous immersion in water. Success Criterion: This Aim will be successful if after 80 min of water immersion, the mean SPF falls within one standard deviation of the pre-immersion SPF of 30. Commercial Opportunity: The global sunscreen market is projected to exceed $2.5 billion by 2023. Primary and secondary market research supports the need for the PHD Sunscreen to meet the emerging needs created by new legislation. Phase II SBIR studies will include additional studies to confirm safety on a larger number of volunteers; compare performance to leading commercial sunscreens; and optimize the chemistry, manufacturing, and control (CMC) processes to produce the product at commercial scale.

项目概要/摘要 待解决的问题及意义：暴露于紫外线辐射（UVR）是导致皮肤病的危险因素 皮肤癌的发生，医疗保健机构建议使用防晒霜作为预防措施 美国和国际上最近的立法禁止销售以下成分。 防水防晒霜的基础，迫切需要新产品来满足现有和 新兴立法。 产品和长期目标：该 SBIR 的产品将是完全生物相容的 SPF 30 广谱 防晒霜，以 6 盎司管装出售，符合 FDA 标记为“防水（80 分钟）”的标准，并且 基于 Nanometics（d.b.a. PHD Biosciences [PHD]）成功的专有弹性体技术。 这种防晒产品的开发直接体现了国家癌症研究所的使命： 提高对紫外线的防护并降低患皮肤癌的风险。 技术创新：PHD防晒霜采用了PHD专有的可生物降解弹性体 技术是第一种用于局部产品的具有防水性的植物衍生弹性体， 与所有美国食品和药物管理局批准的紫外线过滤器兼容，并重现良好的美感 有机硅弹性体的特性。 具体目标 #1：证明 PHD 防晒霜在健康情况下防水至少 80 分钟。 该目标的研究将在 FDA 的指导下进行，并将证明其可行性。 PHD防晒霜在水中连续浸泡80分钟后仍能抵抗水的去除。 标准：如果在水中浸泡 80 分钟后，平均 SPF 落在一个标准范围内，则该目标成功 预浸 SPF 的偏差为 30。 商业机会：预计到​​ 2023 年，全球防晒霜市场将超过 25 亿美元。 主要 二级市场研究支持 PHD 防晒霜的需求，以满足新兴需求 根据新立法，第二阶段 SBIR 研究将包括更多研究，以确认更多的安全性。 志愿者；将性能与领先的商业防晒霜进行比较；并优化化学成分， 以商业规模生产产品的制造和控制 (CMC) 流程。