Safety and Efficacy Study of Vasu Facial Beauty Oil

Launched by NOVOBLISS RESEARCH PVT LTD · Dec 3, 2022

Keywords

ClinConnect 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 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 ...

Gender

ALL

Eligibility criteria

• 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.

Trial Officials