Healthy Clinical Trial
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.
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. ;
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