A Clinical Study to Assess Safety, Efficacy and In-use To... | NCT06551818

NCT06551818

Status Module

Name	Class
Zywie Ventures Privated Ltd	UNKNOWN

Description Module

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SesZen-Bio Low Dose 1 (350 mg extract)	Experimental	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)
SesZen-Bio Low Dose 1 (150 mg liposomal)	Experimental	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)
SesZen-Bio High Dose 1 (500 mg extract)	Experimental	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)
Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 25 to 45 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.
Patient is in good general health as determined by the Investigator on the basis of medical history.
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.
Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
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.
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.
Patients are willing to give written informed consent and are willing to follow the study procedure.
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.
Willing to consume test products throughout the study period.
Patient is willing and able to follow and allow study staff to performed study test methods.
Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
Patient must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria:

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

Name	Role	Phone	Extension	Email
Maheshvari N Patel	Contact	09909013236		maheshvari@novobliss.in
Sheetal J Khandwala	Contact			bd@novobliss.in

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D008567	Membranes, Artificial
D001697	Biomedical and Dental Materials
D004337	Drug Carriers
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D008420	Manufactured Materials
D013676	Technology, Industry, and Agriculture
D040761	Biomimetic Materials