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).

NovoBliss Research Pvt Ltd72 enrolled

Overview

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).

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.

Conditions

Androgenic Alopecia

Interventions

SesZen-Bio Low Dose 1 (350 mg extract)OTHER

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

SesZen-Bio Low Dose 1 (150 mg liposomal)OTHER

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

SesZen-Bio High Dose 1 (500 mg extract)OTHER

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NovoBliss Research Pvt Ltd

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

PlaceboOTHER

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

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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 )

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180