A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionized Water (HAIW) on skin hydration, wrinkles and elasticity in healthy participants

Hydron Alkaline Aqua Pvt. Ltd.1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2025年2月5日最近更新: 2025年8月4日

试验速览

阶段: 2/3 期
状态: 已完成
发起方
入组人数: 120
试验地点: 1
主要终点: Cohort 1:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionized Water (HAIW) on skin hydration, wrinkles and elasticity in healthy participants. The study will be carried out in two cohorts. In cohort 1, moisturizing effect of study products will be evaluated in healthy participants. In cohort 2, anti-ageing (skin wrinkles and elasticity)effect of study products will be evaluated in healthy participants. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking Water in 1:1 ratio. Subject will be asked to consume either HAIW or Packaged Drinking water as and even required for 60 days.

Cohort 1:

The primary objectives of the study will be to assess change in water content (hydration) of the skin surface using Corneometer and change in Trans epidermal water loss (TEWL) using Tewameter. The secondary objectives of the study will be to assess change in skin cutaneous moisturization, skin dryness using clinical grading score, changes in overall skin texture or roughness (Visual) assessed by graded scale, change in Investigator’s Global Assessment on Likert 5 points scale and adverse events, adverse drug reactions including vitals on baseline visit (Day 0), Day 30 and Day 60

Cohort 2:

The primary objectives of the study will be to assess change in skin elasticity and firmness using Cutometer and changes in facial wrinkles (periorbital and perioral) using Fitzpatrick’s classification of wrinkles. The secondary objectives of the study will be to assess change in Investigator’s Global Assessment on Likert 5 points scale, changes in overall skin luminosity, radiance assessed using Global Aesthetic Improvement Scale and adverse events, adverse drug reactions including vitals on baseline visit (Day 0), Day 30 and Day 60

Results and Observations:

This study demonstrates that Hydron Alkaline Ionized Water (HAIW) consumption over 60 days significantly improves skin hydration and moisture content, improves skin texture and reduces perioral wrinkles showing anti-ageing effect compared to Packaged Drinking Water (PDW). HAIW also showed modest, site-specific improvements in skin firmness and elasticity. Use of HIAW did not produce any adverse effects on regular consumption and was observed to be safe for long term continuous use.

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: 18.00 Year(s) 至 50.00 Year(s)（—）
性别: All

入选标准

•Cohort 1:
•Healthy Male and female subjects clinically diagnosed mild to moderate skin dryness
•Willing to comply with all requirements of the study.
•Cohort 2:
•Healthy male and female participants of age between 30-50 years (both inclusive)
•Willing to provide informed consent and comply with all requirements of the study protocol including follow up visits.

排除标准

•Cohort 1:
•Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
•Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right leg which might interfere with the evaluation.
•Subjects with intensive exposure to sunlight or UV rays within the previous month and foreseen during the study.
•Subjects who have used facial blemish-lightening products, topical or oral whitening drugs.
•Moisturizing cream, lotion or oil within 21 days before entering the trial
•Subjects on any other investigational products within 1 month prior to randomization
•Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure, liver failure
•Pregnant and lactating women
•Known hypersensitivity to any of the ingredients of study products
•Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his her participation in, and completion of the study.
•Cohort 2:
•Participants with non intact skin surface for instrumental assessment i.e. wounds, moles etc.
•Participants with a skin tattoo, scars, moles, 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
•Participants diagnosed with anemia or are known cases of diabetes.
•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
•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
•Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his her participation in the study.