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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in hair thickness by using CASLite Nova (instrumental analysis)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 25 to 45 years and above (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Patients having mild to moderate androgenic alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
- •Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Patients are willing to give written informed consent and are willing to follow the study procedure.
- •Patients who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
- •Willing to use test products throughout the study period.
- •Subject is willing and able to follow and allow study staff to performed study test methods.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •Subject who had taken topical treatment of hair loss for at least 4 weeks.
- •Subject who had taken any systemic treatment for at least 3 months.
- •History of alcohol or drug addiction.
- •Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •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.
研究组 & 干预措施
SesZen-Bio Serum
Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully.
Dosage form: liquid Frequency: Daily Night application. Rout of administration: Topical
干预措施: SesZen-Bio Serum (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
干预措施: Minoxidil hair serum (1%) (Other)
Placebo
Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully.
Dosage form: Liquid Frequency: Daily Night Application Rout of administration: Topical
干预措施: Placebo (Other)
Liposomal Form of SesZenBio
Mode of Usage: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully.
Frequency: Daily Night Application Rout of administration: Topical
干预措施: Liposomal Form of SesZenBio (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
干预措施: Minoxidil Hair Serum (5%) (Other)
SesZen-Bio Serum + SesZen-Bio 350 mg extract
Mode of Usage of serum: Dispense a small amount of serum directly onto your fingertips and gently massage it into the roots and scalp using circular motions to ensure even distribution and absorption. Continue this process across your entire scalp, focusing on areas that need the most attention. Avoid rinsing the serum out; instead, allow it to absorb fully.
Frequency: Daily Night Application Rout of administration: Topical Mode of Usage of Capsule: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it.
Frequency: One time daily after meal Rout of administration: Oral
干预措施: SesZen-Bio Serum + SesZen-Bio 350 mg extract (Other)
结局指标
主要结局
Change in hair thickness by using CASLite Nova (instrumental analysis)
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
- Change in general appearance of 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 general appearance of hair dryness(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(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(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(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(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(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(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(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)(Baseline before usage of test product on Day 01 and after usage of test product on Day 180.)
- Change in keratin measurement from scalp by using CASLite Nova (instrumental analysis)(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180.)
- Change in hair length by using CASLite Nova (instrumental analysis) and calibrated ruler(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in A:T ratio by hair pluck test(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180)
- Change hair fall from root test by 60 seconds hair combing test(04 before Day 01, Day 87, Day 90, Day 177 and on Day 180)
- Change in number of new hairs by using CASLite Nova (instrumental analysis)(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in hair regrowth by using CASLite Nova (instrumental analysis)(baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in hair root strength(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(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 keratin measurement from scalp by using CASLite Nova (instrumental analysis)(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180.)
- Change in general appearance of 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 general appearance of hair smoothness(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(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(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(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(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in hair length by using CASLite Nova (instrumental analysis) and calibrated ruler(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change hair fall from root test by 60 seconds hair combing test(04 before Day 01, Day 87, Day 90, Day 177 and on Day 180)
- Change in number of new hairs by using CASLite Nova (instrumental analysis)(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in hair regrowth by using CASLite Nova (instrumental analysis)(baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in general appearance of hair volume(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(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180)
- Change in A:T ratio by hair pluck test(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180)
- Change in hair root strength(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(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(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(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(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(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(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)(Baseline before usage of test product on Day 01 and after usage of test product on Day 180.)