A study to check the hydration benefits
- Registration Number
- CTRI/2023/02/049513
- 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
- 36
1. Male and female subjects in general good health as determined from a recent
medical history, general physical examination, dermatological assessment.
2. Male and female subjects with early signs of aging
3. Subjects with presence of one or more spots or pigmentation/blemishes as per
Investigator discretion
4. Subjects in the age group of 35-50 years (both ages inclusive)
5. Subjects presenting dull and belonging to either one of the skin types dry,
normal or combination
6. Subjects who agree to refrain from using any creams, lotions, moisturizers,
sunscreens or any other skin products on the face for the duration of the study
other than the test product provided,
7. 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.
8. Subjects who agree not to carry out bleaching or any other procedures including
facial etc. on face during the study period.
9. 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).
10. Subjects willing to give a voluntary written informed consent and photography
release,
11. Subjects willing to abide by and comply with the study protocol,
12. Subjects who are willing not to participate in any other clinical study during
participation in the current study,
13. Subjects who have not participated in any clinical product evaluation test within
past 1 month,
14. Subjects able to read and sign an appropriate informed consent form indicating
his/her willingness to participate.
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 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. Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the skin moisturization potential of the investigational product in 4 weeks with respect to the baseline for skin hydration, moisturization, and skin tone associated attributesTimepoint: Baseline, Week 2 & 4
- Secondary Outcome Measures
Name Time Method oneTimepoint: NA