Evaluation of efficacy and safety of NR-INF-IB on skin in healthy participants - A randomized, double-blind, placebo controlled, prospective clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Change in water content hydration of the skin surface assessed using Corneometer
研究概览
简要总结
It is a randomized, double-blind, placebo controlled, prospective clinical study to evaluate efficacy and safety of NR-INF-IB on skin in healthy participants. The study will be carried out in one centre in India. As per computer generated randomization list, subjects will be randomized to one of the four groups (NR-INF-IB-01@250 mg Capsules, NR-INF-IB-02@500 mg Capsules, NR-INF-IB-02@1000 mg Capsules or Placebo capsules) in 1:1:1:1 ratio. Subjects will be asked to consume given product in a dose of 2 capsules once daily for 8 weeks. The primary objectives of the study will be to assess change in water content hydration of the skin surface assessed using Corneometer and change in Trans epidermal water loss (TEWL) assessed using Tewameter. Secondary objectives will be to assess change in skin elasticity assessed using Cutometer, change in skin softness and smoothness on graded scale, change in Investigator’s Global Assessment on Likert 5 points scale and adverse events adverse drug reactions including vitals 0n screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female participants (Healthy individuals will be defined as who do not require any continuous or urgent medical or surgical treatment for any systemic disease.
- •Also with respect to skin, healthy skin will be defined as those without any skin blemishes of infective or non infective pathology like acne, hyper pigmentation or hypopigmentation etc.)
- •Willing to provide informed consent and comply with all requirements of the study protocol including follow up visits.
排除标准
- •1.Participants with non intact skin surface for instrumental assessment (wounds, moles etc.)
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Participants with a skin tattoo, scar(s), mole(s), excessive hairs or any condition of the skin surface, which might interfere with the evaluation.
- •Participants who have been exposed to excessive sunlight or UV-rays within the previous month and are anticipated to be exposed during the study period.
- •Participants diagnosed with anemia or are known cases of diabetes.
- •Participants suffering from any severe or progressive systemic or local disease or any other pathology that may interfere with the evaluation of the study results.
- •Participants with known history of or suffering from autoimmune disease and/or immune deficiency.
- •Participants suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma)
- •Participants having received laser treatment or derma abrasion, surgery, deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 1 month prior to the study
- •Participants having received resorbable filling product (injection) in the cheeks or the neckline area within the past 18 months prior to the study
- •Participants undergoing topical treatment on the test area or a systemic treatment including anti-histamines for the past 2 weeks prior to study; immunosuppressive and or corticoids for the last 4 weeks prior to study; retinoid for the 6 months prior to the study.
- •Known hypersensitivity to any of the ingredients of test products 14.
结局指标
主要结局
1. Change in water content hydration of the skin surface assessed using Corneometer
时间窗: Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8)
2. Change in Trans epidermal water loss (TEWL) assessed using Tewameter
时间窗: Screening visit (up to 3 days), Baseline visit (Day 0), Visit 1 (week 4) and Visit 2 (Week 8)
次要结局
- 1. Change in skin elasticity assessed using Cutometer(2. Change in skin softness and smoothness on graded scale)
研究者
Dr Shaam Agarwal
Target Institute of Medical Education and Research Pvt Ltd.