HealthyNCT05646953
Safety and Efficacy Study of Vasu Facial Beauty Oil
A study testing Facial Beauty Oil in people with Healthy and Wrinkle, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- What is being tested?
- Facial Beauty Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jan 2023to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects
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.
Read the 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.
- Conditions
- Healthy, Wrinkle, Dry Skin, Skin Pigment
- Being tested
- Facial Beauty Oil
- Keywords
- Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Beauty OilOther
Also called Vasu Facial Beauty Oil
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Facial Beauty Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: 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)
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment in improvement in Skin Hydration
To assess the effect of the test product in improvement in Skin hydration by MoistureMeterEPiD
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Change in Facial Photograph
Change in photograph from "before test product usage" and "after test product usage" using DermoPrime Skin | Hair Analyzer or Equivalent
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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
Measured: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start6 Jan 2023
- Primary completion6 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Center, Open Label, Safety and Efficacy
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Vasu Healthcare Private Limited
- Responsible party
- Principal investigator, Dr Nayan Patel, NovoBliss Research Pvt Ltd
- Investigators
- Dr Nayan K Patel, MBBS, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646953
- Sponsor's protocol ID
- NB220033-VH
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT05646953
- Acronym / sponsor ID
- NB220033-VH
- Conditions
- Healthy, Wrinkle, Dry Skin, Skin Pigment
- Keywords
- Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Vasu Healthcare Private Limited
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Center, Open Label, Safety and Efficacy
| Arm | Type | Receives |
|---|---|---|
| Vasu Facial Beauty Oil | Experimental | Other: Facial Beauty OilVasu 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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial Beauty OilAlso: Vasu Facial Beauty OilMode 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 | Other | Vasu Facial Beauty Oil |
Primary outcome
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
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).
11 secondary outcomes
Physician Global Assessments (PGA) scoring using Griffiths scale - Skin dryness, redness, fine wrinkling/lines, coarse wrinkling/lines, laxity, roughness and sallowness
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment of Glogau Skin Age
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment of Skin Pigmentation
Time frame: 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)
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment of Facial Skin Elasticity
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment in improvement in Skin Hydration
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment in improvement in Skin Barrier Function - Transepidermal Water Loss (TEWL)
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Measurement of Skin Brightness and Skin Pigmentation
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment of Occurrence of Acne Lesions by Investigator Global Assessment (IGA) scoring
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Change in Facial Photograph
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Assessment of Product Perception - Sensory Attributes
Time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Nayan K Patel, MBBS principal investigator
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Beauty Oil in people with Healthy and Wrinkle, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Reduction in Facial Wrinkles and Fine lines of Crow's feet area (time frame: On Day 1 before product usage, on Day 30 and Day 60 after test product usage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.