A study of Chewable Gummies for Hair-fall.

Completed

Conditions: Subjects with 50 to 100 hair fall and thin hair will be included in the study.

Registration Number: CTRI/2022/08/044809

Lead Sponsor: Ikaria Wellness Pvt Ltd

Brief Summary: This is an open label, single arm, clinical study to evaluate efficacy and safety of Chewable Gummies in healthy adult subjects with Hair Fall.

Study will consist of total (08) visits.

Visit 01: Screening Visit (07 days prior to Day 01)

Visit 02: For Shaving of Test Area (03 days prior to Day 01)

Visit 03: Enrolment Visit â€“ Baseline Assessment i.e., Day 01

Visit 04: Evaluation Phase i.e., Day 25 (+ 2 Days)

Visit 05: For Shaving of Test Area i.e., Day 47 (Â± 2 Days) (03 days prior to Day 50)

Visit 06: Evaluation Phase i.e., Day 50 (Â± 2 Days)

Visit 07: For Shaving of Test Area i.e., Day 87 (Â± 2 Days) (03 days prior to Day 90)

Visit 08: Evaluation Phase and End of Study i.e., Day 90 (+ 2 Days)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

1.Subjects having 50 to 100 hair fall per day.
2.Females with at least 50 count of hair fall and Males with 30-50 count of hair fall from hair combing method.
(60-sec hair count) 3.Subjects with thin hair.
4.Male subjects with minimum hair length of 2 inches will be included.

Exclusion Criteria

1.History of any dermatological condition of the scalp other than hair loss and/or dandruff.
2.Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
3.Subjects who have undergone hair growth treatment within 3 months before screening.
4.Subjects who are on chronic oral steroids 03 months before initial application and during the study period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anagen and telogen ratio (A:T ratio) by hair pluck test and microscopic evaluation	baseline i.e., Day 01 and after treatment on Day 90 (plus 2 days)

Secondary Outcome Measures

Name	Time	Method
Hair Strength by Hair Pull Test	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Change in general appearance of scalp skin i.e., itchiness, redness, roughness and scaliness of scalp by Dermatologist	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Nail brittleness on the basis of Global improvement rating performed by the Dermatologist	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Nail growth and nail health satisfaction by using 0-10 VAS scale	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Product perception	Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Hair thickness, Hair density and Hair growth by CASlite Nova	baseline on Day 01 and after treatment on Day 50 (plus minus 2 Days) and Day 90 (plus 2 days).
Subject Satisfaction Questionnaire	Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Hair Fall Reduction by counting no. of hair break after 60 second combing method	screening visit, baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Hair Gloss by Glossymeter	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)
Change in general appearance of scalp hair i.e. Hair Volume (Full â€“ Medium â€“ Small), Hair Density (Dense â€“ Thinned/Shed) and Hair Shininess (Poor â€“ Average â€“ Good) by Dermatologist	baseline on Day 01 and Day 25 (plus 2 Days), Day 50 (plus minus 2 Days) and Day 90 (plus 2 Days)

Trial Locations

Locations (1): Cliantha Research
🇮🇳
Ahmadabad, GUJARAT, India
Cliantha Research
🇮🇳Ahmadabad, GUJARAT, India
Dr Parth Joshi
Principal investigator
8000085049
pjoshi@cliantha.com