Safety and Efficacy Study of Vasu Facial Beauty Oil

NCT05646953 | Completed

• 1 other identifier: NB220033-VH
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, single-center, proof-of-concept, exploratory, safety and efficacy, clinical study of a Vasu Facial Beauty Oil in healthy adult human subjects. Considering the proof of concept study, a sufficient number \[maximum of 32 subjects (25 females and 7 males)\] of adult subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. The total clinical study duration is 60 Days from Day 01.

Conditions

Healthy; Wrinkle; Dry Skin; Skin Pigment

Keywords

Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy

Outcome Measures

Primary Outcomes (1)

• Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area

  To evaluate the effectiveness of the test product in reducing the facial wrinkles and fine lines of Crow's feet area in healthy adult human subjects using VisioScan (Instrumental Readings).

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

Secondary Outcomes (11)

• Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

• Assessment of Glogau Skin Age

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

• Assessment of Skin Pigmentation

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

• Assessment of Skin Color L-, a-,b- and ITA (Individual Topology Angle)

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

• Assessment of Facial Skin Elasticity

  On Day 1 before product usage, on Day 30 and Day 60 after test product usage

Study Arms (1)

Vasu Facial Beauty Oil

EXPERIMENTAL

Vasu Facial Beauty Oil blends the Traditional Beauty recipe of Kumkumadi Tailam with clinically- proven Natural Plant Actives to offer a unique product that gives a Natural Glow to face, overcoming hyper-pigmentation, age spots, wrinkles, and blemishes with Avacado, Lavender, Argan, Rapeseed. Kumkumadi Oil is an Ayurvedic Elixir that is effective for many skincare concerns such as Hyperpigmentation, Dark spots, Age spots, Acne scars, Fine lines, Wrinkles as well as Dark circles. It is also used for Beautifying, Rejuvenating and Uplifting the skin.

Other: Facial Beauty Oil

Interventions

Facial Beauty Oil OTHER

Mode of Usage 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 - Use it for 60 days Frequency - Daily before going to bed. Route of Administration - Topical

Also known as: Vasu Facial Beauty Oil

Vasu Facial Beauty Oil

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 25 to 55 years (both inclusive) at the time of consent.
• Sex: Healthy males and non-pregnant/non-lactating females.
• Females of childbearing potential must have a self-reported negative pregnancy test.
• Subjects are generally in good health.
• Subject has a score of at least "mild skin aging" based on Physican Global Assessment (PGA) at screening visit.
• Subject with Glogau Skin Age II or III as assessed by the Dermatologist/Dermatologist Trained Evaluator.
• Subjects with wrinkles at Crow's feet area.
• Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only.
• Subjects with dry skin having ≤ 40% value as evaluated by MoisturemeterEpiD.
• Subject is willing to forgo cosmetic procedures 3 months prior to and for the duration of the study.
• 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.
• Subject is able to follow their normal skin care routines and to refrain from introducing any new skin care products during the study.
• Subject is able to forgo changes in baseline medications and nutritional supplements during the study period.
• If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (Intrauterine Device, 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.
• 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.

You may not qualify if:

• Subject has a history of allergy or sensitivity to the test treatment ingredients like Kumkumadi tailam, avocado, argan, lavender, rapeseed oil and others etc.
• 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.
• Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
• Subject is not willing to avoid the unprotected sun or other UV radiation exposure during the study period.
• Subject is currently pregnant/breastfeeding.
• Subject has a history of alcohol or drug addiction.
• Pregnant or breastfeeding or planning to become pregnant during the study period.
• History of chronic illness which may influence the cutaneous state.
• Subjects participating in other similar cosmetics, devices or therapeutic trials or skin care products within the last four weeks.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Vasu Healthcare Private Limited: collaborator

Study Sites (1)

NovoBliss Research Private Limited

Ahmedabad, Gujarat, 382421, India

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Nayan K Patel, MBBS

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: Single Center, Open Label, Safety and Efficacy

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: January 6, 2023
• Primary Completion: March 6, 2023
• Study Completion: March 31, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)