Standardization of UV Exposure Methods (Artificial Source vs. Sunlight) in Dermatological Research: A Comprehensive Investigation Into the Efficacy Assessment Methodology for Anti-tanning Agents Through Process Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Changes in Melanine index using instrumental assessment
研究概览
简要总结
The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •06 Healthy adult subjects aged between 18 to 45 years (both inclusive).
- •Healthy adult male and non-pregnant|non-lactating females.
- •Female of childbearing potential have self-reported negative urine pregnancy test.
- •Subjects with Fitzpatrick skin types III to V will be included. Alternatively, subjects with a Skin colorimetric Individual Typology Angle (ITA) value ranging from 20° to 41° at the application site (forearms) to be included to ensure a diverse representation of skin tones.
- •Absence of known photosensitivity disorders to maintain the integrity of the study outcomes.
- •Subjects must exhibit a willingness to comply with study plan, including follow-up visits and product applications.
- •No history of skin cancer to or any adverse skin conditions, and not under any medication(s) likely to interfere with the study results.
- •Subjects willing to follow study direction and willing to give written informed consent for the participation.
排除标准
- •Active skin diseases, such as eczema or psoriasis, that could potentially influence skin reactions.
- •Use of photosensitizing medications that interfere with UV-induced skin responses.
- •Pregnancy or breastfeeding status, as hormonal changes during these periods can affect skin reactions.
- •Individuals with a history of severe adverse reactions to skincare or cosmetic products, ensuring participant safety.
- •Presence of open wounds, infections, or cuts at the application sites to prevent complications during the study.
- •Subjects with a history of significant sunburns in the past three months, minimizing the potential for confounding effects.
结局指标
主要结局
Changes in Melanine index using instrumental assessment
时间窗: Days 1, 3 and 7.
Change in melanin index (MI) before and after the exposure as measured using the Changes in melanin index will be measured by using Mexameter® MX 18.
Change in erythema index using instrumental assessment
时间窗: Days 1, 3 and 7.
Change in the erythema index (EI) before and after the exposure as measured using the Mexameter® MX 18.
次要结局
- Change in skin erythema/dryness/wrinkles and oedema using draize scale(Days 1, 3 and 7.)
研究者
Maheshvari Patel
Principal Investigator - Director (Operations)
NovoBliss Research Pvt Ltd