| CTRI Number |
CTRI/2025/01/079438 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on Alkaline Water on skin hydration, wrinkles and elasticity in healthy participants |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAAPL/HAIW/SHWE/2024, Version 1.0, 28th Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaam Agarwal |
| Designation |
Consultant Dermatologist |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Skin Testing Department, Second floor, OPD no 1
Target Institute of Medical Education and Research Pvt. Ltd. E 203, 2nd Floor, Jaymala Business Court, Takle Nagar Manjari BK. Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422026123 |
| Fax |
|
| Email |
drshaam@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd
A wing 402 A,B,C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Hydron Alkaline Aqua Pvt. Ltd. 4A, Trust House, 35 Hospital Avenue, Dr E
Borges Road, Parel Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Hydron Alkaline Aqua Pvt. Ltd. |
| Address |
4A, Trust House, 35 Hospital Avenue, Dr E
Borges Road, Parel Mumbai 400012 |
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaam Agarwal |
Target Institute of Medical Education and Research Pvt. Ltd |
Skin Testing Department, Second floor, OPD no 1
E 203, 2nd Floor, Jaymala Business Court, Besides Satyam Prima, Takle Nagar Manjari BK. Hadapsar Pune-411028
Pune
MAHARASHTRA |
9422026123
drshaam@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. Mhaske Hospital and Research Centre Pvt Ltd Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Dryness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydron Alkaline Ionized Water (HAIW) |
Subject will be asked to consume HAIW as and when required for 60 days. |
| Comparator Agent |
Packaged Drinking Water |
Subject will be asked to consume Packaged Drinking Water as and when required for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cohort 1:
1. Healthy Male and female subjects clinically diagnosed mild to moderate skin dryness
2. Willing to comply with all requirements of the study.
Cohort 2:
1. Healthy male and female participants of age between 30-50 years (both
inclusive)
2. Willing to provide informed consent and comply with all requirements of the
study protocol including follow up visits
|
|
| ExclusionCriteria |
| Details |
Cohort 1:
1. Subjects with a known current history of chronic skin diseases or autoimmune
diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and
rosacea
2. Subjects with a tattoo, a scar, moles, too many hairs or anything on the Right
leg which might interfere with the evaluation.
3. Subjects with intensive exposure to sunlight or UV rays within the previous
month and foreseen during the study.
4. 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
5. Subjects on any other investigational products within 1 month prior to
randomization
6. Subjects with known current tuberculosis, HIV, ischemic heart disease,
cancer, kidney failure, liver failure
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of study products
9. 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:
1. Participants with non intact skin surface for instrumental assessment i.e. wounds, moles etc.
2. Pregnant or nursing woman or planning a pregnancy during the study
3. Participants with a skin tattoo, scars, moles, excessive hairs or any condition
of the skin surface, which might interfere with the evaluation.
4. Participants who have been exposed to excessive sunlight or UV rays within
the previous month
5. Participants diagnosed with or having a history of hypertension, hyper or
hypothyroidism
6. Participants diagnosed with anemia or are known cases of diabetes.
7. 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.
8. Participants with known history of or suffering from autoimmune disease
and or immune deficiency.
9. Participants suffering from inflammatory and or infectious cutaneous
disorders in or near the studied zones
10. 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
11. Participants having received resorbable filling product (injection) in the
cheeks or the neckline area within the past 18 months prior to the study
12. Participants undergoing topical treatment on the test area or a systemic
treatment
13. Known hypersensitivity to any of the ingredients of test products
14. 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort 1:
1. Change in water content (hydration) of the skin surface using Corneometer
2. Change in Trans epidermal water loss (TEWL) using Tewameter
Cohort 2:
1. Change in skin elasticity and firmness using Cutometer
2. Changes in facial wrinkles (periorbital and perioral) using Fitzpatrick’s
classification of wrinkles
|
Baseline visit (Day 0), Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cohort 1
1. Change in skin cutaneous moisturization, skin dryness using clinical grading score.
2. Changes in overall skin texture or roughness Visual assessed by graded scale
3. Change in Investigators Global Assessment on Likert 5 points scale
4. Assessment of adverse events, adverse drug reactions including vitals
Cohort 2
1. Change in Investigators Global Assessment on Likert 5 points scale
2. Changes in overall skin luminosity, radiance assessed using Global Aesthetic Improvement Scale
3. Assessment of adverse events, adverse drug reactions including vitals
|
Baseline visit (Day 0), Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
27/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |