An Exploratory Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Three Different Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III)
NCT Number: NCT06556056
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Androgenic Alopecia
Interventions: OTHER: SesZen-Bio Serum|OTHER: Minoxidil hair serum (1%)|OTHER: Placebo
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Zywie Ventures Privated Ltd
Sex: ALL
Age: ADULT
Enrollment: 54
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2024-08-30
Completion Date: 2025-03-02

Summary:
This is an exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth products in the patients mild to moderate androgenic alopecia (Grade I to III).

Primary Outcome Measures: Change in hair thickness by using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in hair thickness., Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180.|Change in hair density by using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in hair density, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180.|Change in hair growth rate using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in hair growth rate, 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
Secondary Outcome Measures: Change in keratin measurement from scalp by using CASLite Nova (instrumental analysis), To evaluate the effectiveness of test products in terms of change in keratin measurement from scalp from Androgenic Alopecia affected targeted area and normal scalp- tattoo area, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180.|Change in hair length by using CASLite Nova (instrumental analysis) and calibrated ruler, To assess the effectiveness of the test products in terms of change in hair length from androgenic alopecia affected targeted area and standard area, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in A:T ratio by hair pluck test, To assess the effectiveness of the test products in terms of change in A:T ratio by dermatologist, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180|Change hair fall from root test by 60 seconds hair combing test, To assess the effectiveness of the test products in terms of change hair fall by dermatologist, 04 before Day 01, Day 87, Day 90, Day 177 and on Day 180|Change in number of new hairs by using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in number of new hairs, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in hair regrowth by using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in hair regrowth from androgenic alopecia affected targeted area, baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in hair root strength, To assess the effectiveness of the test products in terms of change in hair root strength by dermatologist., Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90, Day 135 and on Day 180|Change in general appearance of hair volume, To assess the effectiveness of the test products in terms of change in general appearance of hair volume in which score done as small, medium, full, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair plasticity, To assess the effectiveness of the test products in terms of change in general appearance of hair plasticity in which score done as waved and average, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair density, To assess the effectiveness of the test products in terms of change in general appearance of hair density in which score as thinned and dense, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair dryness, To assess the effectiveness of the test products in terms of change in general appearance of hair dryness in which score done as 1= none, and 4= Excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair shininess, To assess the effectiveness of the test products in terms of change in general appearance of hair shininess in which score done as 1= poor average and 3=good, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair smoothness, To assess the effectiveness of the test products in terms of change in general appearance of hair smoothness in which score done as 1= poor, and 3= good, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair oiliness, To assess the effectiveness of the test products in terms of change in general appearance of hair oiliness in which score done as 1= none and 4=excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of hair strength, To assess the effectiveness of the test products in terms of change in general appearance of hair strength in which score done as poor, average and good, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of scalp Itchiness, To assess the effectiveness of the test products in terms of change in general appearance of scalp Itchiness in which score done as none, mild, moderate and excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of scalp redness, To assess the effectiveness of the test products in terms of change in general appearance of scalp redness in which score done as none, mild, moderate and excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of scalp roughness, To assess the effectiveness of the test products in terms of change in general appearance of scalp roughness in which score done as none, mild, moderate and excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of scalp scaliness, To assess the effectiveness of the test products in terms of change in general appearance of scalp scaliness in which score done as none, mild, moderate and excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in general appearance of scalp dryness, To assess the effectiveness of the test products in terms of change in general appearance of scalp dryness in which score done as 1= none, and 4=excessive, Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in products perception questionnaire in which 5-point Likert scale as 1= not at all and 5= to large extent, 10. To evaluate the effectiveness of the test products in terms of change in products perception questionnaire, Before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180|Change in tensile strength of hairs by TESTRONIX tensile tester (instrumental analysis), To assess the effectiveness of the test products in terms of change in tensile strength of hairs, Baseline before usage of test product on Day 01 and after usage of test product on Day 180.