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A Clinical Study to check the Safety and Efficacy of Vasu Facial Beauty Oil in Healthy Adult Human Subjects.

A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048265
Enrollment
32
Registered
2022-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Vasu Facial Beauty Oil: Step 1- Wash face, pat dry Step 2- Gently massage 2-3 drops of Vasu Facial Beauty Oil over the face and neck till it gets absorbed and keep it overnight. Step 3-

Sponsors

Vasu Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Change in a photograph from â??before test product usageâ?? and â??after test product usageâ??Timepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of test product in terms of change in Skin brightness and skin pigmentation reductionTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in improvement in Skin barrier function in terms of a decrease in Transepidermal Water Loss (TEWL)Timepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in improvement in Skin elasticityTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in improvement in Skin hydrationTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in terms of change in Glogau Skin AgeTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in terms of change in Physician Global Assessment (PGA) scoring using Griffiths scale â?? Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallownessTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in terms of change in skin colour i.e. L- a- b- and ITA angleTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in terms of instant change in skin pigmentationTimepoint: On Day 01 Before Product usage and Day 30, Day 60 after test product usage;To assess the effect of the test product in terms of treatment perception regarding the test productâ??s effect on skin firmness, appearance, radiance, the occurrence of acne breakouts, glowing skin tone, blemishes and dark skin patches rem

Countries

India

Contacts

Public ContactMaheshvari Patel

NovoBliss Research Private Limited

dr.nayan@novobliss.in91-99013286

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026