Healthy Clinical Trial
Official title:
A Proof-of-Concept, Safety and Efficacy Study of Vasu Facial Beauty Oil in Healthy Adult Human Subjects
Verified date | April 2023 |
Source | NovoBliss Research Pvt Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility | 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. Subjects are generally in good health. 5. Subject has a score of at least "mild skin aging" based on Physican Global Assessment (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 Crow's feet area. 8. Subjects with uneven texture skin, uneven skin tone, with dry to normal skin only. 9. Subjects with dry skin having = 40% value as evaluated by MoisturemeterEpiD. 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 (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. 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: 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 the 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 dermatologist's/investigator'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. |
Country | Name | City | State |
---|---|---|---|
India | NovoBliss Research Private Limited | Ahmedabad | Gujarat |
Lead Sponsor | Collaborator |
---|---|
NovoBliss Research Pvt Ltd | Vasu Healthcare Private Limited |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | On Day 1 before product usage, on Day 30 and Day 60 after test product usage | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |