An Exploratory Clinical Study to Assess Safety, Efficacy and In-Use Tolerability of Three Different Hair Growth Products in Patients With Mild to Moderate Androgenic Alopecia (Grade I to III)

NCT06556056 | Completed

• 1 other identifier: NB240029-ZV
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth products in the patients 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 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 (22)

• Change in keratin measurement from scalp 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 by using CASLite Nova (instrumental analysis) and calibrated ruler

  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 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 (6)

SesZen-Bio Serum

EXPERIMENTAL

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: liquid Frequency: Daily Night application. Rout of administration: Topical

Other: SesZen-Bio Serum

Minoxidil Hair Serum (1%)

ACTIVE COMPARATOR

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liquid Frequency: Daily Night Application Rout of administration: Topical

Other: Minoxidil hair serum (1%)

Placebo

PLACEBO COMPARATOR

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liquid Frequency: Daily Night Application Rout of administration: Topical

Other: Placebo

Liposomal Form of SesZenBio

EXPERIMENTAL

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical

Other: Liposomal Form of SesZenBio

Minoxidil Hair Serum (5%)

EXPERIMENTAL

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical

Other: Minoxidil Hair Serum (5%)

SesZen-Bio Serum + SesZen-Bio 350 mg extract

EXPERIMENTAL

Mode of Usage of serum: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical Mode of Usage of Capsule: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Frequency: One time daily after meal Rout of administration: Oral

Other: SesZen-Bio Serum + SesZen-Bio 350 mg extract

Interventions

SesZen-Bio Serum OTHER

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liduid Frequency: Daily Night application. Route of administration: Topical

SesZen-Bio Serum

Minoxidil hair serum (1%) OTHER

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liquid Frequency: Daily Night Application Route of administration: Topical

Minoxidil Hair Serum (1%)

Placebo OTHER

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liquid Frequency: Daily Night Application Route of administration: Topical

Placebo

Liposomal Form of SesZenBio OTHER

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical

Liposomal Form of SesZenBio

Minoxidil Hair Serum (5%) OTHER

Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical

Minoxidil Hair Serum (5%)

SesZen-Bio Serum + SesZen-Bio 350 mg extract OTHER

Mode of Usage of serum: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical Mode of Usage of Capsule: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Frequency: One time daily after meal Rout of administration: Oral

SesZen-Bio Serum + SesZen-Bio 350 mg extract

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.
• Subject 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.
• Subject 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 subject 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 use test products throughout the study period.
• Subject is willing and able to follow and allow study staff to performed study test methods.
• Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
• Subject must be able to understand and provide written informed consent to participate in the study.

You may not qualify if:

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

Study Sites (1)

NovoBliss Research Private Limited

Ahmedabad, Gujarat, 382481, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

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 15, 2024
• Study Start: June 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 9, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)