Clinical trial on skin health
- Registration Number
- CTRI/2019/08/020761
- Lead Sponsor
- Katra Phytochem India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
i. Subjects in generally good health
ii. Subjects age group 20 - 50 years
iii. Subjects willing to give a written informed consent and come for a regular follow up
iv. Subject willing to abide by and comply with the study protocol
v. Subject has not participated in a similar investigation in the past four weeks.
vi. Subjects having visible fine lines and wrinkles in periorbital area (Crowâ??s feet), nasolabial areas, forehead , and perioral regions of the face
vii. Subjects having mild to moderate naso-labial folds
viii. Subjects having apparent mild to moderate crowâ??s feet in unanimated face
ix. Subjects who have not under gone any facial anti-ageing procedures (e.g.Botulinum dermal filler injections, laser resurfacing) in the past 3 months.
x. Subject should be willing to abstain from spa treatments/facials during the study period
i. A known history or present condition of allergic response to any cosmetic products.
ii. Subjects having severe photo-aging.
iii. Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
iv. Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
v. Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
vi. Subjects not willing to discontinue other topical anti-ageing, anti-wrinkle facial products.
vii. Subjects who are pregnant, lactating or nursing.
viii. Hypersensitivity to any component of the tested products.
ix. History of intense sun exposure.
x. Chronic illness which may influence the cutaneous state.
xi. Subject participating in any other cosmetic or therapeutic trial.
xii. 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 i. Dermatologistâ??s visual assessment. <br/ ><br>ii. Instrumental measurements- Visioscan, Visioline, Cutometer, Corneometer & Chromameter. <br/ ><br>iii. Assessment with imaging system- Image pro II. <br/ ><br>iv. Subjectâ??s self-assessmentTimepoint: Day 0, Day 90
- Secondary Outcome Measures
Name Time Method a. Procollagen <br/ ><br>b. Collagen producing gene <br/ ><br>c. Fibrillin <br/ ><br>d. Elastin <br/ ><br>e. HAS-1 (Hyaluronic acid synthase-1) <br/ ><br>f. MMPs (matrix Metalloproteinase): <br/ ><br>g. TEWL ((Transepidermal water loss) <br/ ><br>h. Skin elasticity <br/ ><br>i. Stratum corneum flexibility <br/ ><br>j. Skin roughness & Skin wrinkleTimepoint: Day 0 and Day 90