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).

NCT06551818 | Not Yet Recruiting

• 1 other identifier: NB240030-ZV
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Androgenic Alopecia

Outcome Measures

Primary Outcomes (3)

• 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 (55)

• Change in keratin measurement from hair by using CASLite Nova (instrumental 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 hair length

  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

  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

  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)

  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

Study Arms (4)

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

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 (350 mg extract)

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 Low Dose 1 (150 mg liposomal)

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

SesZen-Bio High Dose 1 (500 mg extract)

Placebo 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

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Zywie Ventures Privated Ltd: collaborator

MeSH Terms

Conditions

Alopecia

Interventions

Liposomes

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal J Khandwala

CONTACT

bd@novobliss.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 13, 2024
• Study Start: August 30, 2024
• Primary Completion: March 2, 2025
• Study Completion: March 2, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share