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| Name | Class |
|---|---|
| Vasu Healthcare Private Limited | INDUSTRY |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Nayan K Patel, MBBS | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Private Limited | Ahmedabad | Gujarat | 382421 | India |
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| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single Center, Open Label, Safety and Efficacy
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Open Label
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | On Day 1 before product usage, on Day 30 and Day 60 after test product usage |