A study to check the hydration benefits
- Registration Number
- CTRI/2023/02/049444
- Lead Sponsor
- HNL Business Services India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1. A total 35 male and female subjects (25:75% i.e., 9 males :26 females
respectively) in general good health as determined from a recent medical
history, general physical examination, dermatological assessment.
2. Subjects in the age group of 35-50 years (both ages inclusive).
Subjects belonging to one of the skin types dry, normal, oily or combination
3. Subjects presenting dull and dry skin (normal to dry), along with early signs of aging (Signs of aging with mild to moderate (includes wrinkles-crow’s feet, nasolabial and frown lines) using 0-9 MSCR scale
4. Subjects free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face as determined by the dermatologist.
5. Subject who agrees not to use any other product/treatment/home remedy/
except the provided product on their face during the study period other than the test product.
6. Subjects who agree not to carry out bleaching or any other procedures
including facial etc. on face during the study period.
7. Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face).
8. Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
9. Subjects willing to abide by and comply with the study protocol.
1. Subject with any other signs of significant local irritation or skin disease.
2. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
3. Subject having clinically significant systemic or cutaneous disease, chronic illness or had major surgery in the last year.
4. Subjects who do not agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible nose ring), during VISIA CR imaging.
5. Subjects having hair style which covers almost the entire forehead
6. Subjects undergoing any treatment of any skin condition on their face
7. Subjects not willing to discontinue other topical facial products.
8. Subject allergic or sensitive to bar, cleansing products, cosmetics, creams/lotions, artificial jewellery or anything else.
9. Pregnant women (as confirmed by UPT) and lactating women
10. Subjects on any medical treatment either systemic/topical in the past 1 month or currently taking medication including food supplements.
11. Subjects with skin allergy, history of atopic dermatitis or psoriasis
12. Subjects who have participated in any other clinical trial in the last 3 months.
13. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study
14. Subjects who have undergone treatment with Botox/filler /bio stimulatory
molecules injection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Significant improvement in skin hydration <br/ ><br>2. Significant improvement in deep nourishment <br/ ><br>3. Significant reduction in sign of ageingTimepoint: Baseline, Week 2, 4 & 8
- Secondary Outcome Measures
Name Time Method oneTimepoint: NA