A Clinical Study to Assess Safety, Efficacy and In-use Tolerability of Different Dosages of Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III).
NCT Number: NCT06551818
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Androgenic Alopecia
Interventions: OTHER: SesZen-Bio Low Dose 1 (350 mg extract)|OTHER: SesZen-Bio Low Dose 1 (150 mg liposomal)|OTHER: SesZen-Bio High Dose 1 (500 mg extract)|OTHER: Placebo
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Zywie Ventures Privated Ltd
Sex: ALL
Age: ADULT
Enrollment: 72
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 a prospective, interventional, exploratory, four-arm - dose response study, comparative, double-blind, randomized, placebo-control, proof of concept, safety, efficacy and in-use tolerability study of three different dosage formulation of test hair growth products and placebo in patients with 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 by 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 hair by using CASLite Nova (instrumental analysis), To assess the effectiveness of the test products in terms of change in keratin from Androgenic Alopecia affected targeted area and normal scalp- tattoo area measurement from hair, 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, To assess the effectiveness of the test products in terms of change in hair length (AG affected area and standard area) by using CASLite Nova (instrumental analysis) followed by Image pro-analysis (software analysis), 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 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 dermatological assessment, 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 1= small 3=full, baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 1=waved and 3=average, baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 1=thinned and 2=dense, baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 and on Day 180|Change in products perception questionnaire, To evaluate the effectiveness of the test products in terms of change in products perception questionnaire by using 5-point Likert scale in which 1= not at all and 5= to large extent, 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 by TESTRONIX tensile tester (instrumental assessment), 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.|Change in nail brittleness, To evaluate the effect of test products in terms of change in nail brittleness in which score done by 5 liert scale in which 1-not at all and 5- to large extent, Baseline before usage of test product on Day 01 and after usage of test products and on Day 180|Change in CBC- haemoglobin, To evaluate the effect of test products in terms of change in CBC- haemoglobin, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC- haematocrit, To evaluate the effect of test products in terms of change in CBC- haematocrit, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC- RBC (Red Blood Corpuscle), To evaluate the effect of test products in terms of change in CBC- RBC (Red Blood Corpuscle), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC-MCH (mean corpuscular hemoglobin), To evaluate the effect of test products in terms of change in CBC- MCH (mean corpuscular hemoglobin), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC- MCV (mean corpuscular volume), To evaluate the effect of test products in terms of change in CBC- MCV (mean corpuscular volume), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC- MCHC (mean corpuscular haemoglobin concentration), To evaluate the effect of test products in terms of change in CBC- MCHC (mean corpuscular haemoglobin concentration), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CBC- WBC (White Blood Cell), To evaluate the effect of test products in terms of change in CBC- WBC (White Blood Cell), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase), To evaluate the effect of test products in terms of change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase ), To evaluate the effect of test products in terms of change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- serum creatinine, To evaluate the effect of test products in terms of change in Biochemistry- serum creatinine, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- BUN (blood urea nitrogen), To evaluate the effect of test products in terms of change in Biochemistry- BUN (blood urea nitrogen), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- RBS (random blood sugar), To evaluate the effect of test products in terms of change in Biochemistry- RBS (random blood sugar), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- PPBS (post-prandial blood sugar), To evaluate the effect of test products in terms of change in Biochemistry- PPBS (post-prandial blood sugar), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- TC (Total cholesterol ), To evaluate the effect of test products in terms of change in Biochemistry- TC (Total cholesterol ), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- TG (Triglyceride levels), To evaluate the effect of test products in terms of change in Biochemistry- TG (Triglyceride levels), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- HDL (high-density lipoproteins), To evaluate the effect of test products in terms of change in Biochemistry- HDL (high-density lipoproteins), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- LDL (low-density lipoproteins), To evaluate the effect of test products in terms of change in Biochemistry- LDL (low-density lipoproteins), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- uric acid, To evaluate the effect of test products in terms of change in Biochemistry- uric acid, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in Biochemistry- VLDL (very low-density lipoprotein), To evaluate the effect of test products in terms of change in Biochemistry- VLDL (very low-density lipoprotein), Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in testosterone, To evaluate the effect of test products in terms of change in testosterone, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in free testosterone, To evaluate the effect of test products in terms of change in free testosterone, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in dihydrotestosterone, To evaluate the effect of test products in terms of change in dihydrotestosterone, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in CRP (C-reactive protein), To evaluate the effect of test products in terms of change in CRP (C-reactive protein), Before usage of test products on Day 01 from baseline and after usage of test products on Day 180|Change in random cortisol, To evaluate the effect of test products in terms of change random cortisol, Before usage of test products on Day 01 from baseline and after usage of test products on Day 180|Change in ferritin, To evaluate the effect of test products in terms of change in ferritin, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis - albumin, To evaluate the effect of test products in terms of change in urinalysis-albumin, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-blood, To evaluate the effect of test products in terms of change in urinalysis-blood, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-glucose, To evaluate the effect of test products in terms of change in urinalysis-glucose, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-pH, To evaluate the effect of test products in terms of change in urinalysis-pH, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-colour, To evaluate the effect of test products in terms of change in urinalysis-colour, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-appearance, To evaluate the effect of test products in terms of change in urinalysis-appearance, Baseline before usage of test products on Day 01 and after usage of test products on Day 180|Change in urinalysis-deposits, To evaluate the effect of test products in terms of change in urinalysis-deposits, Baseline before usage of test products on Day 01 and after usage of test products on Day 180