A Clinical Study to check the Safety and Efficacy of Vasu Facial Beauty Oil in Healthy Adult Human Subjects.
- Registration Number
- CTRI/2022/12/048265
- Lead Sponsor
- Vasu Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1)Age: 25 to 55 years (both inclusive) at the time of consent.
2)Sex: Healthy males and non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative pregnancy test.
4)Subject are generally in good health.
5)Subject has a score of at least â??mild skin agingâ?? based on PGA at screening visit.
6)Subject with Glogau Skin Age II or III as assessed by the Dermatologist/ Dermatologist Trained Evaluator.
7)Subjects with wrinkles at Crowâ??s feet area.
8)Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only.
9)Subjects with dry skin having <= 40% value as evaluated by MoisturemeterEpiD.
10)Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
11)Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
12)Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
13)Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
14)If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
15)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
16)Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study.
17)Subjects are willing to give written informed consent and are willing to follow the study procedure.
18)Subjects who have used other marketed products for hair thinning in the past.
19)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil / Anti-thinning agents) or any other hair growth, treatment for thin hair, or hair products other than the test product for the entire duration of the study.
20)Willing to use test product throughout the study period.
1)Subject has a history of allergy or sensitivity to the test treatment ingredients like Kumkumadi tailam, avocado, argan, lavender, rapeseed oil and others etc.
2)Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
3)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
4)Subject is not willing to avoid unprotected sun or other UV radiation exposure during the study period.
5)Subject is currently pregnant/breastfeeding.
6)Subject has a history of alcohol or drug addiction.
7)Any other condition which could warrant exclusion from the study, as per the dermatologistâ??s/investigatorâ??s discretion.
8)Pregnant or breastfeeding or planning to become pregnant during the study period.
9)History of chronic illness which may influence the cutaneous state.
10)Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effectiveness of the test product in reducing the facial wrinkles and fine lines of Crowâ??s feet areaTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage
- Secondary Outcome Measures
Name Time Method