Effect of serum in helathy humans
- Registration Number
- CTRI/2021/07/034980
- Lead Sponsor
- ITC Life Sciences Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1.Female subjects in general good health in the age range of 18-45 years.
2.Subjects who are willing to use the face serum (and no other leave on moisturizer/serum) during the study duration (7 days) and not apply any product for next 3 days.
3.Subjects willing to not apply any product on volar forearms and come for evaluation at the said time points
4.Subjects who score greater than 30 for sensitive vs resistant skin questionnaire in Dr. Baumannââ?¬•s questionnaire.
5.Subjects who show no irritation up till 30 minutes for product applied behind ear lobe
6.Subjects willing to give a written informed consent and come for regular follow up
7.Subjects who have not participated in a similar investigation in the past eight weeks
1.Subjects with a present condition of allergic response to any cosmetic product
2.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines etc.) that might influence the outcome of the study.
3.Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids, or any other anti-acne medication) or any topical facial medication within past 4 weeks.
4.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy).
5.Having mild, moderate or severe acne.
6.Subjects with excessive facial hair or scars, which could interfere
7.Subjects with a present condition of allergic response to any cosmetic product.
8.Subjects having cutaneous hypersensitivity.
9.Subjects participating in any other cosmetic or therapeutic trial.
10.Subjects having changed her cosmetic habits required as per protocol before the start of the study on the studied site.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: <br/ ><br>To evaluate the skin hydration benefits of test products with 7 days of regular usage <br/ ><br>To evaluate the maintenance of skin hydration for 72 hours <br/ ><br>Part 2: <br/ ><br>To evaluate and compare moisturization benefit at 5 min, 24, 48 and 72 hours post product application in comparison to baseline and untreated control <br/ ><br>To determine the efficacy of test products in providing deep moisturization benefit after tape stripping at 0, 3, 6, 10, 15 strips in comparison to baseline and untreated controlTimepoint: Part 1 - Baseline, Day 4, Day 8 and Day 10 <br/ ><br>part 2 - Baseline, Immediate, 24, 48 and 72 hrs
- Secondary Outcome Measures
Name Time Method To evaluate the impact of skin hydrating serum of other associated skin parameters such as texture, elasticity/firmness, skin glow, barrier property etc <br/ ><br>To evaluate the product safety and tolerance of the test product/s by dermatological assessment.Timepoint: Part 1 - Baseline, Day 4, Day 8 and Day 10 <br/ ><br>part 2 - Baseline, Immediate, 24, 48 and 72 hrs