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| Name | Class |
|---|---|
| Zywie Ventures Privated Ltd | UNKNOWN |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Liposomal Form of SesZenBio | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SesZen-Bio Serum | Other | Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liduid Frequency: Daily Night application. Route of administration: Topical |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hair thickness by using CASLite Nova (instrumental analysis) | To assess the effectiveness of the test products in terms of change in hair thickness. | Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180. |
| Change in hair density by using CASLite Nova (instrumental analysis) | To assess the effectiveness of the test products in terms of change in hair density | Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180. |
| Change in hair growth rate using CASLite Nova (instrumental analysis) | To assess the effectiveness of the test products in terms of change in hair growth rate | 04 before Day 01, Day 01, Day 87, Day 90, Day 177 and on Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Nayan K Patel | NovoBliss Research Pvt Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Private Limited | Ahmedabad | Gujarat | 382481 | India |
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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%) | 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 |
|
| 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 |
|
|
| 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 |
|
| Placebo | Other | Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Dosage form: Liquid Frequency: Daily Night Application Route of administration: Topical |
|
| Liposomal Form of SesZenBio | Other | Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical |
|
| 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 extract | Other | Mode of Usage of serum: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully. Frequency: Daily Night Application Rout of administration: Topical Mode of Usage of Capsule: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it. Frequency: One time daily after meal Rout of administration: Oral |
|
| 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 | 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 10. To evaluate the effectiveness of the test products in terms of change in products perception questionnaire | 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 | Baseline before usage of test product on Day 01 and after usage of test product on Day 180. |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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