Androgenic AlopeciaNCT06551818
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).
A study testing SesZen-Bio Low Dose 1 (350 mg extract), SesZen-Bio Low Dose 1 (150 mg liposomal) and SesZen-Bio High Dose 1 (500 mg extract) in people with Androgenic Alopecia, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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… 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 Low Dose 1 (350 mg extract), SesZen-Bio Low Dose 1 (150 mg liposomal) and SesZen-Bio High Dose 1 (500 mg extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 23 Sep 2024to 7 Jul 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
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).
Read the 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.
- Conditions
- Androgenic Alopecia
- Being tested
- SesZen-Bio Low Dose 1 (350 mg extract), SesZen-Bio Low Dose 1 (150 mg liposomal), SesZen-Bio High Dose 1 (500 mg extract), Placebo
- 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 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 (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 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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Placebo |
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 by 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 (55)
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
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
To assess the effectiveness of the test products in terms of change in hair length (AG affected area and standard area) by using CASLite Nova (instrumental analysis) followed by Image pro-analysis (software analysis)
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 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 dermatological assessment
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 1= small 3=full
Measured: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 1=waved and 3=average
Measured: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 1=thinned and 2=dense
Measured: baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 and on Day 180
Change in products perception questionnaire
To evaluate the effectiveness of the test products in terms of change in products perception questionnaire by using 5-point Likert scale in which 1= not at all and 5= to large extent
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 by TESTRONIX tensile tester (instrumental assessment)
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.
Change in nail brittleness
To evaluate the effect of test products in terms of change in nail brittleness in which score done by 5 liert scale in which 1-not at all and 5- to large extent
Measured: Baseline before usage of test product on Day 01 and after usage of test products and on Day 180
Change in CBC- haemoglobin
To evaluate the effect of test products in terms of change in CBC- haemoglobin
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- haematocrit
To evaluate the effect of test products in terms of change in CBC- haematocrit
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- RBC (Red Blood Corpuscle)
To evaluate the effect of test products in terms of change in CBC- RBC (Red Blood Corpuscle)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC-MCH (mean corpuscular hemoglobin)
To evaluate the effect of test products in terms of change in CBC- MCH (mean corpuscular hemoglobin)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- MCV (mean corpuscular volume)
To evaluate the effect of test products in terms of change in CBC- MCV (mean corpuscular volume)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- MCHC (mean corpuscular haemoglobin concentration)
To evaluate the effect of test products in terms of change in CBC- MCHC (mean corpuscular haemoglobin concentration)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- WBC (White Blood Cell)
To evaluate the effect of test products in terms of change in CBC- WBC (White Blood Cell)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase)
To evaluate the effect of test products in terms of change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase )
To evaluate the effect of test products in terms of change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- serum creatinine
To evaluate the effect of test products in terms of change in Biochemistry- serum creatinine
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- BUN (blood urea nitrogen)
To evaluate the effect of test products in terms of change in Biochemistry- BUN (blood urea nitrogen)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- RBS (random blood sugar)
To evaluate the effect of test products in terms of change in Biochemistry- RBS (random blood sugar)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- PPBS (post-prandial blood sugar)
To evaluate the effect of test products in terms of change in Biochemistry- PPBS (post-prandial blood sugar)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- TC (Total cholesterol )
To evaluate the effect of test products in terms of change in Biochemistry- TC (Total cholesterol )
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- TG (Triglyceride levels)
To evaluate the effect of test products in terms of change in Biochemistry- TG (Triglyceride levels)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- HDL (high-density lipoproteins)
To evaluate the effect of test products in terms of change in Biochemistry- HDL (high-density lipoproteins)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- LDL (low-density lipoproteins)
To evaluate the effect of test products in terms of change in Biochemistry- LDL (low-density lipoproteins)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- uric acid
To evaluate the effect of test products in terms of change in Biochemistry- uric acid
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- VLDL (very low-density lipoprotein)
To evaluate the effect of test products in terms of change in Biochemistry- VLDL (very low-density lipoprotein)
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in testosterone
To evaluate the effect of test products in terms of change in testosterone
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in free testosterone
To evaluate the effect of test products in terms of change in free testosterone
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in dihydrotestosterone
To evaluate the effect of test products in terms of change in dihydrotestosterone
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CRP (C-reactive protein)
To evaluate the effect of test products in terms of change in CRP (C-reactive protein)
Measured: Before usage of test products on Day 01 from baseline and after usage of test products on Day 180
Change in random cortisol
To evaluate the effect of test products in terms of change random cortisol
Measured: Before usage of test products on Day 01 from baseline and after usage of test products on Day 180
Change in ferritin
To evaluate the effect of test products in terms of change in ferritin
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis - albumin
To evaluate the effect of test products in terms of change in urinalysis-albumin
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-blood
To evaluate the effect of test products in terms of change in urinalysis-blood
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-glucose
To evaluate the effect of test products in terms of change in urinalysis-glucose
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-pH
To evaluate the effect of test products in terms of change in urinalysis-pH
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-colour
To evaluate the effect of test products in terms of change in urinalysis-colour
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-appearance
To evaluate the effect of test products in terms of change in urinalysis-appearance
Measured: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in urinalysis-deposits
To evaluate the effect of test products in terms of change in urinalysis-deposits
Measured: Baseline before usage of test products on Day 01 and after usage of test products 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 posted13 Aug 2024
- Study start23 Sep 2024
- Primary completion7 Jun 2025
- Study completion7 Jul 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
- 72 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
- NCT06551818
- Sponsor's protocol ID
- NB240030-ZV
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 31 Jul 2026
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT06551818
- Acronym / sponsor ID
- NB240030-ZV
- Conditions
- Androgenic Alopecia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Zywie Ventures Privated Ltd
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 13 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 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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SesZen-Bio Low Dose 1 (350 mg extract) | Experimental | Other: SesZen-Bio Low Dose 1 (350 mg extract)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) | Experimental | Other: SesZen-Bio Low Dose 1 (150 mg liposomal)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) | Experimental | Other: SesZen-Bio High Dose 1 (500 mg extract)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 | Placebo comparator | Other: PlaceboMode 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 |
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.
- 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.
Key exclusion criteria (12 listed)
- 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.
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 Low Dose 1 (350 mg extract)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)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)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) |
| PlaceboMode 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 |
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 by 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
55 secondary outcomes
Change in keratin measurement from hair 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 and on Day 180
Change in products perception questionnaire
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 by TESTRONIX tensile tester (instrumental assessment)
Time frame: Baseline before usage of test product on Day 01 and after usage of test product on Day 180.
Change in nail brittleness
Time frame: Baseline before usage of test product on Day 01 and after usage of test products and on Day 180
Change in CBC- haemoglobin
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- haematocrit
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- RBC (Red Blood Corpuscle)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC-MCH (mean corpuscular hemoglobin)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- MCV (mean corpuscular volume)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- MCHC (mean corpuscular haemoglobin concentration)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in CBC- WBC (White Blood Cell)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- SGOT (serum glutamic oxaloacetic transaminase)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- SGPT (serum glutamic oxaloacetic transaminase )
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- serum creatinine
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- BUN (blood urea nitrogen)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- RBS (random blood sugar)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- PPBS (post-prandial blood sugar)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- TC (Total cholesterol )
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- TG (Triglyceride levels)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- HDL (high-density lipoproteins)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products on Day 180
Change in Biochemistry- LDL (low-density lipoproteins)
Time frame: Baseline before usage of test products on Day 01 and after usage of test products 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 31 Jul 2026.
- 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 Low Dose 1 (350 mg extract), SesZen-Bio Low Dose 1 (150 mg liposomal) and SesZen-Bio High Dose 1 (500 mg extract) 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 31 Jul 2026. 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 31 Jul 2026.