Proof-of-Science, Prospective, Interventional, Three-arm, Double-Blind, Randomized, Safety and Efficacy Real World Evidence Study.
99 participantsStarted 2024-08-24
Plain-language summary
This is proof-of-science, prospective, interventional, three-arm, double-blind, randomized, safety and efficacy real world evidence study of herbal and non herbal formulations in healthy human subjects having complaint of hair fall and pre-mature graying.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18 to 55 years and above (both inclusive) at the time of consent.
✓. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
✓. Females of childbearing potential must have a self-reported negative urine pregnancy.
✓. Subject is in good general health as determined by the Investigator on the basis of medical history.
✓. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
✓. Subject having AGA and premature Gray hair at a time of screening.
✓. Subject having premature gray hair at a time of screening.
✓. Subject with pro-claimed nonpathological thinning of hair.
Exclusion criteria
✕. Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
✕. Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
✕. Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
✕. Subject who had taken topical treatment of hair loss for at least 4 weeks.
✕. Subject who had taken any systemic treatment for at least 3 months.
✕. History of alcohol or drug addiction.
✕. Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
✕. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
What they're measuring
1
change in hair thickness by using CASLite Nova
Timeframe: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
2
change in hair density by using CASLite Nova
Timeframe: Baseline before usage of test product on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120
3
change in hair growth rate by using CASLite Nova
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90 and Day 120 .
4
change in hair strength by using hair pull test.
Timeframe: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120
5
change in hair fall by using 60 second hair combing test.
Timeframe: Baseline before usage of the test products (04 days before Day 01) and after usage of the test on Day 45, Day 90 and Day 120.
6
change in scalp skin hydration by using Corneometer CM 825
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 and Day 120
change in Anagen: Telogen (A: T) Ratio by using Hair Pluck Test by dermatologist.
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120
8
change in ASFS by using ASFS scoring scale.
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 (+2 days), Day 90 (3 days from the visit 04) and Day 120 (+2 days)
9
change in GSS score by using CASLite Nova
Timeframe: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 120 (+2 days)