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)

NCT ID: NCT06556056

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-06-30

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).

Detailed Description

A total of up to 54 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 45 patients (15 patients/ arm) to complete the study. Additional arm 4, 18subjects was added to complete 15, as an open-label, exploratory, prospective, interventional arm to evaluate the efficacy and safety of the liposomal form of SesZen Bio serum, with comparative reference to the Minoxidil arm. Following further, two more open-label arms-Arm 5 and Arm 6- have now been incorporated into the study to evaluate the comparative efficacy and safety of 5% Minoxidil and combination therapy consisting of SesZen Bio capsules (350 mg standardized extract) with the SesZen Bio serum. Each arm will enrol 18 healthy subjects to achieve 15 evaluable subjects per arm

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 1(Day -04): Screening, Tattoo creation, hair growth measurement. Visit 02(Day 01): Enrolment, hair growth rate measurement, hair length, 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.

Visit 03 (Day 45): Hair Length, hair thickness, hair density, scalp condition for keratin measurement, hair regrowth, number of hair fall from root, number of new hairs from the full scalp, AG affected, 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 (03 days from visit 04)]:Hair growth rate measurement, hair length, hair thickness, hair density, scalp condition for keratin measurement, A: T ratio, hair regrowth, number of new hairs, 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, hair thickness, hair density, scalp condition for keratin measurement, hair regrowth, number of hair fall from root, number of new hair, 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 (03 days from Visit 07)]: Hair growth rate measurement, hair length, hair thickness, hair density, scalp condition for keratin measurement, A: T Ratio, number of new hair, hair regrowth, 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

Conditions

Androgenic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

SesZen-Bio Serum

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

Group Type: EXPERIMENTAL

SesZen-Bio Serum

Intervention Type: 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

Minoxidil Hair Serum (1%)

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

Group Type: ACTIVE_COMPARATOR

Minoxidil hair serum (1%)

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Liposomal Form of SesZenBio

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

Group Type: EXPERIMENTAL

Liposomal Form of SesZenBio

Intervention Type: 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%)

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

Group Type: EXPERIMENTAL

Minoxidil Hair Serum (5%)

Intervention Type: 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

SesZen-Bio Serum + SesZen-Bio 350 mg extract

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

Group Type: EXPERIMENTAL

SesZen-Bio Serum + SesZen-Bio 350 mg extract

Intervention Type: 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

Interventions

SesZen-Bio Serum

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

Intervention Type: OTHER

Minoxidil hair serum (1%)

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Liposomal Form of SesZenBio

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

Intervention Type: OTHER

Minoxidil Hair Serum (5%)

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

Intervention Type: OTHER

SesZen-Bio Serum + SesZen-Bio 350 mg extract

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

Intervention Type: OTHER

Eligibility Criteria

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. Subject 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. 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.

8. 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.

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 use test products throughout the study period.

12. Subject is willing and able to follow and allow study staff to performed study test methods.

13. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.

14. Subject must be able to understand and provide written informed consent to participate in the study.

Exclusion Criteria

1. Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.

2. Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.

3. Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).

4. Subject who had taken topical treatment of hair loss for at least 4 weeks.

5. Subject who had taken any systemic treatment for at least 3 months.

6. History of alcohol or drug addiction.

7. Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.

8. Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.

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. Subject have participated any clinical research study related to hair care products.

12. 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zywie Ventures Privated Ltd

UNKNOWN

Sponsor Role: collaborator

NovoBliss Research Pvt Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Nayan K Patel

Role: PRINCIPAL_INVESTIGATOR

NovoBliss Research Pvt Ltd

Locations

NovoBliss Research Private Limited

Ahmedabad, Gujarat, India

Countries

India

Other Identifiers

NB240029-ZV

Identifier Type: -

Identifier Source: org_study_id