None listed
Conditions
Interventions
Intervention1: Hydron Alkaline Ionized Water (HAIW): Subject will be asked to consume HAIW as and when required for 60 days.
Control Intervention1: Packaged Drinking Water: Subject will be asked to co
Sponsors
Hydron Alkaline Aqua Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Baseline visit (Day 0), Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Baseline visit (Day 0), Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed