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Safety and Efficacy Study of Vasu Facial Beauty Oil

Primary Purpose

Healthy, Wrinkle, Dry Skin

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Facial Beauty Oil
Sponsored by
NovoBliss Research Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy focused on measuring Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study. Subjects are willing to give written informed consent and are willing to follow the study procedure. Subjects who have used other marketed products for hair thinning in the past. 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. Willing to use test product throughout the study period. Exclusion Criteria: 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. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. 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.

Sites / Locations

  • NovoBliss Research Private Limited

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vasu Facial Beauty Oil

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
To assess the effect of the test product in terms of change in Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness by Dermatologist Trained Evaluator
Assessment of Glogau Skin Age
To assess the effect of the test product in terms of change in Glogau Skin Age by Dermatologist Trained Evaluator
Assessment of Skin Pigmentation
To assess the effect of the test product in terms of instant change in skin pigmentation by a Dermatologist Trained Evaluator
Assessment of Skin Color L-, a-,b- and ITA (Individual Topology Angle)
To assess the effect of the test product in terms of change in skin colour i.e. L* a* b* and ITA (Individual Topology Angle) using Skin-Colorimeter CL 400
Assessment of Facial Skin Elasticity
To assess the effect of the test product in improvement in Skin elasticity by DermaLab Combo or Cutometer Dual MPA 580
Assessment in improvement in Skin Hydration
To assess the effect of the test product in improvement in Skin hydration by MoistureMeterEPiD
Assessment in improvement in Skin Barrier Function - Transepidermal Water Loss (TEWL)
To assess the effect of the test product on improvement in Skin barrier function in terms of decrease in Transepidermal Water Loss (TEWL) using Vapometer
Measurement of Skin Brightness and Skin Pigmentation
To assess the effect of test product in terms of change in Skin brightness and skin pigmentation reduction by Dermatologist Trained Evaluator
Assessment of Occurrence of Acne Lesions by Investigator Global Assessment (IGA) scoring
To assess the occurrence of Acne lesion in terms of IGA Scoring for Acne Severity by Dermatologist Trained Evaluator
Change in Facial Photograph
Change in photograph from "before test product usage" and "after test product usage" using DermoPrime Skin | Hair Analyzer or Equivalent
Assessment of Product Perception - Sensory Attributes
To assess the effect of the test product in terms of treatment perception regarding the test product's effect on skin firmness, appearance, radiance, the occurrence of acne breakouts, glowing skin tone, blemishes, dark skin patch removal, etc. based on study participants subjective ratings

Full Information

First Posted
December 3, 2022
Last Updated
April 12, 2023
Sponsor
NovoBliss Research Pvt Ltd
Collaborators
Vasu Healthcare Private Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05646953
Brief Title
Safety and Efficacy Study of Vasu Facial Beauty Oil
Official Title
A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
March 6, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NovoBliss Research Pvt Ltd
Collaborators
Vasu Healthcare Private Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 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 adult female/male subjects will be instructed to visit the facility as per the below visits. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations Visit 02 (Day 30 i.e. week 4): Treatment Period, Evaluations Visit 03 (Day 60 i.e. week 8): Evaluations, End of Study Visit Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up or use any hair product on the study visit day. Assessment of efficacy parameters before test product usage will be done on day 1, and after test, product usage will be done on day 30, and day 60 as listed below. Skin Elasticity: Derma Lab Combo or Cutometer Dual MPA 580 (Right Cheek) MoistureMeterEPiD: Skin Hydration (Right cheek) Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek) Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b*, ITA Angle (Individual Typology Angle) Visioscan: Crow's feet area wrinkles, fine lines, skin texture - roughness, dryness, wrinkles, smoothness Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness, and sallowness Glogau Skin Age Skin Pigmentation Scoring Occurrence of Acne - Investigator Global Assessment (IGA) score for assessment of Acne Severity Digital Photographs: Facial photographs Before test product usage and after test product usage using DermoPrime or equivalent. Subjective Product Perception Assessment regarding the test product's effect on skin firmness, appearance, radiance, the occurrence of acne breakouts, glowing skin tone, blemishes, dark skin patch removal, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Wrinkle, Dry Skin, Skin Pigment
Keywords
Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Center, Open Label, Safety and Efficacy
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vasu Facial Beauty Oil
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Facial Beauty Oil
Other Intervention Name(s)
Vasu Facial Beauty Oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area
Description
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).
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Secondary Outcome Measure Information:
Title
Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
Description
To assess the effect of the test product in terms of change in Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness by Dermatologist Trained Evaluator
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Glogau Skin Age
Description
To assess the effect of the test product in terms of change in Glogau Skin Age by Dermatologist Trained Evaluator
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Skin Pigmentation
Description
To assess the effect of the test product in terms of instant change in skin pigmentation by a Dermatologist Trained Evaluator
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Skin Color L-, a-,b- and ITA (Individual Topology Angle)
Description
To assess the effect of the test product in terms of change in skin colour i.e. L* a* b* and ITA (Individual Topology Angle) using Skin-Colorimeter CL 400
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Facial Skin Elasticity
Description
To assess the effect of the test product in improvement in Skin elasticity by DermaLab Combo or Cutometer Dual MPA 580
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment in improvement in Skin Hydration
Description
To assess the effect of the test product in improvement in Skin hydration by MoistureMeterEPiD
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment in improvement in Skin Barrier Function - Transepidermal Water Loss (TEWL)
Description
To assess the effect of the test product on improvement in Skin barrier function in terms of decrease in Transepidermal Water Loss (TEWL) using Vapometer
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Measurement of Skin Brightness and Skin Pigmentation
Description
To assess the effect of test product in terms of change in Skin brightness and skin pigmentation reduction by Dermatologist Trained Evaluator
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Occurrence of Acne Lesions by Investigator Global Assessment (IGA) scoring
Description
To assess the occurrence of Acne lesion in terms of IGA Scoring for Acne Severity by Dermatologist Trained Evaluator
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Change in Facial Photograph
Description
Change in photograph from "before test product usage" and "after test product usage" using DermoPrime Skin | Hair Analyzer or Equivalent
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Title
Assessment of Product Perception - Sensory Attributes
Description
To assess the effect of the test product in terms of treatment perception regarding the test product's effect on skin firmness, appearance, radiance, the occurrence of acne breakouts, glowing skin tone, blemishes, dark skin patch removal, etc. based on study participants subjective ratings
Time Frame
On Day 1 before product usage, on Day 30 and Day 60 after test product usage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Subjects are willing not to introduce any new soaps, cleansers, laundry detergents, lotions, creams, shampoos etc. for the duration of the study. Subjects are willing to give written informed consent and are willing to follow the study procedure. Subjects who have used other marketed products for hair thinning in the past. 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. Willing to use test product throughout the study period. Exclusion Criteria: 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. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Nayan K Patel, MBBS
Organizational Affiliation
Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
NovoBliss Research Private Limited
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
382421
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy Study of Vasu Facial Beauty Oil

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