A Clinical Study to Assess the Safety and Effectiveness of Plant Based Biotin in Healthy Human Subjects With Thin, Dry, and Brittle Hair
Condition: Hair Thinning; Hair Brittle; Dry Hair
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      This is a randomized, placebo-controlled, double-blind, two-arm, single-centre,
      proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in
      Healthy Human Subjects with thin, dry, and brittle hair.

      a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were
      recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.
    

Detailed description: 
      This is a randomised, placebo-controlled, double-blind, two-arm, single-centre,
      proof-of-concept, clinical study to evaluate the safety and efficacy of Plant based Biotin in
      Healthy Human Subjects with thin, dry and brittle hair.

      a sufficient number (maximum of 54 (27/arm)) of female/male adult subjects were
      recruited/enrolled to ensure a total of 50 subjects (25 subjects/arm) completed the study.

      total of 51 subjects was completed the study. The potential subjects were screened as per the
      inclusion & exclusion criteria only after obtaining written informed consent from the
      subjects. The adult female/male subjects were instructed to visit the facility as per the
      below visits.

        -  Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluations

        -  Visit 02 (Day 28): Treatment Period, Evaluations

        -  Visit 03 (Day 56): Evaluations, End of Study Visit Subjects were pre-screened by the
           screening department of NovoBliss Research. Subjects were called on the telephone by the
           recruiting department prior to the enrolment visit. Subjects were 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 treatment usage was done on day 1, and after
      test treatment usage was done on day 28, and day 56 as listed below.

        -  General Appearance of Hair i.e., hair volume, hair reflection, hair plasticity, hair
           density, hair smoothness, hair oiliness, hair shininess.

        -  General Appearance of Scalp i.e., Scalp itchiness, redness, scaling.

        -  CASLite Nova: Hair Density, Thickness, scalp condition

        -  Visioscan (C+K Instrument): Crow's feet area wrinkles, fine lines, skin texture -
           roughness,

        -  Skin Colorimeter CL 400: Right cheek skin colour evenness L*, a* b* and RGB, ITA Angle

        -  DermaLab®Combo - skin elasticity (Right cheek)

        -  MoitureMeterEPiD: Skin Hydration (Right cheek)

        -  Vapometer: Skin Barrier function - Transepidermal water loss (Right cheek)

        -  Physician Global Assessment for improvement in brittle nails - Day 01 and Day 56

        -  Serum Ferratin Biomarker test (Day 1 as baseline and Day 56)

        -  Digital Photographs: Facial photographs Before test treatment usage and after test
           treatment usage.

        -  Subjective Product Perception Assessment regarding the test product's effect on hair and
           skin firmness, appearance, nails etc
    

Intervention name(s): SesZen-Bio™; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): mode of usage: 1 capsule in the morning and 1 capsule at night. administration: Oral Administration; Mode of Usage: 1 capsule in the morning and 1 capsule at night. Route of Administration: Oral Administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Proof-of-Concept, Placebo-Controlled, Safety, and Efficacy
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care