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.

项目总结/摘要 待解决的问题及意义：紫外线辐射（UVR）暴露是一个危险因素， 皮肤癌的发展，卫生保健机构建议使用防晒霜作为预防措施， measure.美国和国际上最近的立法已经禁止销售成分， 这是防水防晒霜的基础，迫切需要新产品来满足现有和 新兴立法。 产品和长期目标：本SBIR的产品将是完全生物相容的SPF 30广谱 防晒霜，以6盎司管出售，符合FDA的标准，被标记为“防水（80分钟）”， 基于Nanometics（D.B.A.）PHD Biosciences [PHD]）专有弹性体技术。成功 这种防晒产品的开发直接解决了国家癌症研究所的使命， 提高对紫外线辐射的防护，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，这是第一个植物衍生的弹性体局部产品，提供防水， 与所有食品和药物管理局批准的紫外线过滤器兼容，并概括了有利的美学 有机硅弹性体的性能。 具体目标#1。为了证明PHD防晒霜在健康皮肤上防水至少80分钟， 志愿者本目标研究将在FDA指导下进行，并将证明以下可行性： 在水中连续浸泡80分钟后，PHD防晒剂耐用水除去。成功 标准：如果浸水80分钟后，平均SPF值福尔斯在一个标准范围内，则该目标成功 预浸SPF的偏差为30。 商业机会：到2023年，全球防晒霜市场预计将超过25亿美元。初级 二级市场研究支持PHD防晒霜的需求，以满足新兴的需求， 通过新的立法。II期SBIR研究将包括额外的研究，以确认大量 志愿者;将性能与领先的商业防晒霜进行比较;并优化化学， 生产和控制（CMC）工艺，以商业规模生产产品。