Androgenic AlopeciaNCT06556056
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)
A study testing SesZen-Bio Serum, Minoxidil hair serum (1%) and Liposomal Form of SesZenBio in people with Androgenic Alopecia, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- SesZen-Bio Serum, Minoxidil hair serum (1%) and Liposomal Form of SesZenBio
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteIndia
- Study dates
- 30 Jun 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory, Prospective, Three-arm, Interventional, Comparative, Randomized, Double-blind, Placebo-controlled, Safety, Efficacy and In-use Tolerability Study of Hair Growth Product(s) in Patients With Mild to Moderate Androgenic Alopecia: (Grade I to III)
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).
Read the 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
- Being tested
- SesZen-Bio Serum, Minoxidil hair serum (1%), Placebo, Liposomal Form of SesZenBio, Minoxidil Hair Serum (5%)
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SesZen-Bio SerumOther
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%)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
PlaceboOther
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 SesZenBioOther
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%)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 extractOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: SesZen-Bio Serum + SesZen-Bio 350 mg extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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)
To evaluate the effectiveness of test products in terms of change in keratin measurement from scalp from Androgenic Alopecia affected targeted area and normal scalp- tattoo area
Measured: 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
To assess the effectiveness of the test products in terms of change in hair length from androgenic alopecia affected targeted area and standard area
Measured: 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
To assess the effectiveness of the test products in terms of change in A:T ratio by dermatologist
Measured: 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
Measured: 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)
To assess the effectiveness of the test products in terms of change in number of new hairs
Measured: 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
Measured: 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 dermatologist.
Measured: 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 small, medium, full
Measured: 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 plasticity
To assess the effectiveness of the test products in terms of change in general appearance of hair plasticity in which score done as waved and average
Measured: 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 density
To assess the effectiveness of the test products in terms of change in general appearance of hair density in which score as thinned and dense
Measured: 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 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
Measured: 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 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 average and 3=good
Measured: 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 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
Measured: 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 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
Measured: 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 strength
To assess the effectiveness of the test products in terms of change in general appearance of hair strength in which score done as poor, average and good
Measured: 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 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 none, mild, moderate and excessive
Measured: 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 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 none, mild, moderate and excessive
Measured: 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 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 none, mild, moderate and excessive
Measured: 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 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 none, mild, moderate and excessive
Measured: 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 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 1= none, and 4=excessive
Measured: 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 products perception questionnaire in which 5-point Likert scale as 1= not at all and 5= to large extent
- To evaluate the effectiveness of the test products in terms of change in products perception questionnaire
Measured: 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 of hairs by TESTRONIX tensile tester (instrumental analysis)
To assess the effectiveness of the test products in terms of change in tensile strength of hairs
Measured: Baseline before usage of test product on Day 01 and after usage of test product on Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start30 Jun 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Zywie Ventures Privated Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556056
- Sponsor's protocol ID
- NB240029-ZV
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Prospective, Three-arm, Interventional, Comparative, Randomized, Double-blind, Placebo-controlled, Safety, Efficacy and In-use Tolerability Study of Hair Growth Product(s) in Patients With Mild to Moderate Androgenic Alopecia: (Grade I to III)
- ClinicalTrials.gov ID
- NCT06556056
- Acronym / sponsor ID
- NB240029-ZV
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Zywie Ventures Privated Ltd
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SesZen-Bio Serum | Experimental | Other: SesZen-Bio SerumMode 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 |
| Minoxidil Hair Serum (1%) | Active comparator | 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 Rout of administration: Topical |
| Placebo | Placebo comparator | Other: PlaceboMode 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 |
| Liposomal Form of SesZenBio | Experimental | Other: Liposomal Form of SesZenBioMode 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%) | Experimental | 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 |
| SesZen-Bio Serum + SesZen-Bio 350 mg extract | Experimental | Other: SesZen-Bio Serum + SesZen-Bio 350 mg extractMode 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 |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SesZen-Bio SerumMode 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 | Other | SesZen-Bio Serum |
| 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 | Other | Minoxidil Hair Serum (1%) |
| PlaceboMode 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 | Other | Placebo |
| Liposomal Form of SesZenBioMode 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%)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 extractMode 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 |
Primary outcome
Change in hair thickness by using CASLite Nova (instrumental 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.
To assess the effectiveness of the test products in terms of change in hair thickness.
Change in hair density by using CASLite Nova (instrumental 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.
To assess the effectiveness of the test products in terms of change in hair density
Change in hair growth rate using CASLite Nova (instrumental analysis)
Time frame: 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180
To assess the effectiveness of the test products in terms of change in hair growth rate
22 secondary outcomes
Change in keratin measurement from scalp by using CASLite Nova (instrumental 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.
Change in hair length by using CASLite Nova (instrumental analysis) and calibrated ruler
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 A:T ratio by hair pluck test
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
Time frame: 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)
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)
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
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
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 plasticity
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 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 general appearance of hair dryness
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 shininess
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 smoothness
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 oiliness
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 strength
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 scalp Itchiness
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 scalp redness
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 scalp roughness
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 scalp scaliness
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 scalp dryness
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 products perception questionnaire in which 5-point Likert scale as 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 of hairs by TESTRONIX tensile tester (instrumental analysis)
Time frame: Baseline before usage of test product on Day 01 and after usage of test product on Day 180.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SesZen-Bio Serum, Minoxidil hair serum (1%) and Liposomal Form of SesZenBio in people with Androgenic Alopecia, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hair thickness by using CASLite Nova (instrumental 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.