To evaluate Efficacy and in use tolerance of Oral Sun Protection Nutraceutical Tablet in Men and Women with Melasma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. 3D Imaging for Skin Tone evenness and hyperpigmentation.
研究概览
简要总结
The skin is a major protective organ of the body. It is constantly exposed to the environment
and is very resilient. But exposure to ultraviolet (UV) rays from the sun results in the
production of reactive oxygen species (ROS) and subsequent inflammatory responses that can
overwhelm the innate protective mechanisms of the skin. This results in damage and
premature aging. Strategies to mitigate this premature photoaging might include avoidance of
sunlight. However, some sunlight exposure is beneficial to health. One notable example of this
is the production of vitamin D. A more practical approach to preventing adverse effects of UV
light in the skin is antioxidant supplementation. Dietary antioxidants may help control ROS
propagation following UV light exposure. To further evaluate the utility of antioxidants in
protecting the skin a study will be required.
This study will be carried out to evaluate Safety and Efficacy of Oral Sun Protection
Nutraceutical Tablet in Men and Women with Melasma using objective instrument
measurements, clinical evaluation and subjective self-assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary men and or women from 18 years to 55 years of age with mild to moderate melasma will be included.
- •Photo type III to IV.
- •Having otherwise healthy skin on test area.
- •Participants showing abnormal levels in blood test parameters.
- •(Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigator’s Discretion).
- •Willing to avoid unusual sun exposure as far as possible for the entire study duration.
- •Accepting not to use oral supplement with the same end benefit during the entire study duration.
- •Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •Ready to provide consent, having been informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •Female who is pregnant (UPT)or lactating women.
- •Participants hypersensitive to any of the components of the test product.
- •Participants on any systemic medical treatment which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •Participant in an exclusion period or participating in any clinical trial within 30 days prior to screening.
结局指标
主要结局
1. 3D Imaging for Skin Tone evenness and hyperpigmentation.
时间窗: Day 0, Day 30, Day 60
2. Melasma Area Severity Index (MASI Scale) for the assessment of melasma.
时间窗: Day 0, Day 30, Day 60
3. Self-assessment for product efficacy.
时间窗: Day 0, Day 30, Day 60
次要结局
- Self-assessment questionnaire for in use tolerance.(Day 30, Day 60)
研究者
Dr Rajiv Joshi
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.