Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Liposomal form of SesZen-Bio: 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 ensu
instead, allow it to absorb fully.
Frequency: Daily Night Application
Route of administration: Topical
Total Duration: 180 Days
Intervention2: Minoxidil Hair Serum (1%)
: Mode of usage: Dispense a sm
instead, allow it to absorb fully.
Dose: small amount or as required
Dosage form: liquid
frequency: Daily night application
Route of administration: Topical
Total Duration: 180 Days
Intervention3: Min
instead, allow it to absorb fully.
Frequency: Daily Night Application
Route of administration: Topical
Total Duration: 180 Days
Intervention4: Placebo: Mode of usage: Dispense a small amount of serum
Sponsors
Zywie Ventures Privated Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 25 to 45 years and above (both inclusive) at the time of consent. 2) Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females). 3) Females of childbearing potential must have a self-reported negative urine pregnancy. 4) Subject is in good general health as determined by the Investigator on the basis of medical history. 5) Patients having mild to moderate androgenic alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female. 6) Female with 40-50 counts and male with 25 -30 counts of hair fall at screening. 7) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study. 8) If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation. 9) Patients are willing to give written informed consent and are willing to follow the study procedure. 10) Patients who commit not to use any other medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study. 11) Willing to use test products throughout the study period. 12) Subject is willing and able to follow and allow study staff to performed study test methods. 13) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits. 14) Subject must be able to understand and provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems. 2) Subject have history of any dermatological condition of the scalp other than hair loss and dandruff. 3) Subject have history of any prior hair growth procedures (e.g. hair transplant or laser). 4) Subject who had taken topical treatment of hair loss for at least 4 weeks. 5) Subject who had taken any systemic treatment for at least 3 months. 6) History of alcohol or drug addiction. 7) Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease. 8) Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study. 9) Pregnant or breast feeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state. 11) Subject have participated any clinical research study related to hair care products. 12) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova 2.To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova Timepoint: 1. 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 2. 04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, on Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of the test products in terms of change in keratin measurement from scalp by using CASLite Nova(From Androgenic Alopecia affected targeted area and normal scalp- tattoo area)Timepoint: 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;2. To assess the effectiveness of the test products in terms of change in hair length by using CASLite Nova and calibrated rulerTimepoint: 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 A:T ratio by hair pluck testTimepoint: Baseline before usage of the test products on Day 01 and after usage of the test products on Day 90 and on Day 180;To assess the effectiveness of the test products in terms of change hair fall from root test by 60 seconds hair combing testTimepoint: 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 number of new hairs by using CASLite NovaTimepoint: 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 regrowth by using CASLite NovaTimepoint: 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 strength from root by dermatological assessmentTimepoint: 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 general appearance of hair i.e. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed