Safety and Efficacy Study of Vasu Facial Beauty Oil
Condition: Healthy; Wrinkle; Dry Skin; Skin Pigment
MeSH terms: Pigmentation Disorders
Study type: Interventional

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 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.
    

Intervention name(s): Facial Beauty Oil
Intervention type(s): Other
Intervention description(s): 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
Other intervention name(s): Vasu Facial Beauty Oil
Intervention model: Single Group Assignment
Intervention model description: Single Center, Open Label, Safety and Efficacy
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy, Dry Skin, Wrinkles, Pigmentation, Safety, Efficacy