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).

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).

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: 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

Detailed Description

A total of up to 72 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 60 patients (15 patients/ arm) to complete the study.

There will be total of 8 visits during the study. The duration of the study will be 180 days (6 months) from the enrolment.

Visit 01 (Day -04): Screening, Tattoo creation, hair growth measurement. Visit 02(Day 01):Enrolment, hair growth rate measurement, hair length (androgenic affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, number of new hairs, number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, earlier product perception questionnaire, global pictures of head crown, CBC, Biochemical tests, free testosterone, testosterone, dihydrotestosterone, CRP, Cortisol random, ferritin, urinalysis.

Visit 03 (Day 45): Hair Length (Androgenic Alopecia affected targeted area standard area), hair thickness, hair density, scalp condition for keratin measurement, hair regrowth (AG affected area), number of hair fall from root, number of new hairs (full scalp and normal scalp- tattoo area), hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, global pictures of head crown.

Visit 04 (Day 87): Tattoo creation, hair growth measurement Visit 05 (Day 90):Hair growth rate measurement, hair length (Androgenic Alopecia affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, hair regrowth (AG affected area), number of new hairs (on full scalp, normal scalp- tattoo area), number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, digital photographs of global pictures head crown.

Visit 06 (Day 135):Hair length (Androgenic Alopecia affected targeted area and standard area), hair thickness, hair density, scalp condition for keratin measurement, hair regrowth (AG affected area), number of hair fall from root, number of new hair (on full scalp, normal scalp- tattoo area), hair root strength from root, general appearance of hair, general appearance of scalp, product perception questionnaire, digital photographs of global pictures head crown.

Visit 07 (Day 177): Tattoo creation, hair growth measurement Visit 08 (Day 180): Hair growth rate measurement, hair length (standard area and Androgenic Alopecia affected targeted area), hair thickness, hair density, scalp condition for keratin measurement, A: T Ratio, number of new hair (on full scalp, AG affected area), hair regrowth (AG affected area), number of hair fall from root, hair root strength, general appearance of hair, general appearance of scalp, product perception questionnaire, global pictures of head crown CBC, Biochemical tests, free testosterone, testosterone, dihydrotestosterone, CRP, Cortisol random, ferritin, urinalysis.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheetal J Khandwala; Email: bd@novobliss.in
• Study Contact Backup: Name: Maheshvari N Patel; Phone Number: 09909013236; Email: maheshvari@novobliss.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 25 to 45 years and above (both inclusive) at the time of consent.
2. Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
3. Females of childbearing potential must have a self-reported negative urine pregnancy.
4. Patient is in good general health as determined by the Investigator on the basis of medical history.
5. Patients having mild to moderate Androgenic Alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
6. Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
7. Patient is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
8. If the patient is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
9. Patients are willing to give written informed consent and are willing to follow the study procedure.
10. Patients who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
11. Willing to consume test products throughout the study period.
12. Patient is willing and able to follow and allow study staff to performed study test methods.
13. Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
14. Patient must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
2. Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
3. Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
4. Patient who had taken topical treatment of hair loss for at least 4 weeks.
5. Patient who had taken any systemic treatment for at least 3 months.
6. History of alcohol or drug addiction.
7. Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8. Patient who is currently participating in or planning on starting weight loss program that may result in a significant change in overall body weight.
9. Pregnant or breast feeding or planning to become pregnant during the study period.
10. History of chronic illness which may influence the cutaneous state.
11. Patient have participated any clinical research study related to hair care products.
12. Patient have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SesZen-Bio Low Dose 1 (350 mg extract); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: capsule Frequency: One time daily after meal Rout of administration: Oral	Other: SesZen-Bio Low Dose 1 (350 mg extract); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
Experimental: SesZen-Bio Low Dose 1 (150 mg liposomal); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: capsule Frequency: One time daily after meal Rout of administration: Oral	Other: SesZen-Bio Low Dose 1 (150 mg liposomal); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
Experimental: SesZen-Bio High Dose 1 (500 mg extract); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: capsule Frequency: One time daily after meal Rout of administration: Oral	Other: SesZen-Bio High Dose 1 (500 mg extract); Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral
Placebo Comparator: Placebo; Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: capsule Frequency: One time daily after meal Rout of administration: Oral	Other: Placebo; Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Dosage form: Capsule Frequency: One time daily after meal Rout of administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Collaborators: Zywie Ventures Privated Ltd
• Investigators: Principal Investigator: Dr. Nayan K Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2024
• Primary Completion (Estimated): March 2, 2025
• Study Completion (Estimated): March 2, 2025

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: NB240030-ZV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No