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).
Scientific Title of Study
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).
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NB240030-ZV version 1.0 15Jul24
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nayan Patel
Designation
Principal Investigator-Medical Director
Affiliation
NovoBliss Research Private Limited
Address
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar GUJARAT 382421 India
Phone
7948983895
Fax
Email
dr.nayan@novobliss.in
Details of Contact Person Scientific Query
Name
Dr Nayan Patel
Designation
Principal Investigator-Medical Director
Affiliation
NovoBliss Research Private Limited
Address
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,
GUJARAT 382421 India
Phone
7948983895
Fax
Email
dr.nayan@novobliss.in
Details of Contact Person Public Query
Name
Maheshvari Patel
Designation
Director Operations and Strategic Management
Affiliation
NovoBliss Research private Limited
Address
NovoBliss Research Pvt. Ltd. Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar GUJARAT 382421 India
Phone
9909013236
Fax
Email
maheshvari@novobliss.in
Source of Monetary or Material Support
Zywie Ventures Privated Ltd
Dashrath Singh Estate,
Caves Road, Near Jogeshwari Caves,
Jogeshwari East, Mumbai – 400060
Maharashtra, India
Primary Sponsor
Name
Zywie Ventures Privated Ltd
Address
Dashrath Singh Estate,
Caves Road, Near Jogeshwari Caves,
Jogeshwari East, Mumbai – 400060
Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NA
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Nayan Patel
NovoBliss Research Pvt. Limited
Clinical trial department Office# A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Nr. Vaishnodevi Circle, Khoraj, Gandhinagar GUJARAT
Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it.
Dose: one time daily after meal
Dosage form: Capsule
Frequency: Once daily
Route of administration: Oral
Total duration : 180 Days
Intervention
SesZen-Bio - Liposomal
Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it.
Dose: one time daily after meal
Dosage form: Capsule
Frequency: Once daily
Route of administration: Oral
Total duration : 180 Days
Intervention
SesZen-Bio High Dose
Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it.
Dose: one time daily after meal
Dosage form: Capsule
Frequency: Once daily
Route of administration: Oral
Total duration : 180 Days
Intervention
SesZen-Bio Low Dose
Mode of Usage: Swallow the capsule whole with a full glass of water without chewing, crushing, or opening it.
Dose: one time daily after meal
Dosage form: Capsule
Frequency: Once daily
Route of administration: Oral
Total duration : 180 Days
Inclusion Criteria
Age From
25.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
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)Patient 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)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.
8)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.
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 consume test products throughout the study period.
12)Patient is willing and able to follow and allow study staff to performed study test methods.
13)Patient is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
14)Patient must be able to understand and provide written informed consent to participate in the study.
ExclusionCriteria
Details
1)Patient have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
2)Patient have history of any dermatological condition of the scalp other than hair loss and dandruff.
3)Patient have history of any prior hair growth procedures (e.g. hair transplant or laser).
4)Patient who had taken topical treatment of hair loss for at least 4 weeks.
5)Patient who had taken any systemic treatment for at least 3 months.
6)History of alcohol or drug addiction.
7)Patient having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
8)Patient who is currently participating in or planning on starting weight loss program that
may result in a significant change in overall body weight.
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)Patient have participated any clinical research study related to hair care products.
12)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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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
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, Day 180.
Secondary Outcome
Outcome
TimePoints
1. To assess the effectiveness of the test products in terms of change in keratin measurement from hair by using CASLite Nova
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 (AG affected area and standard area) by using CASLite Nova and calibrated ruler respectively
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
3. To assess the effectiveness of the test products in terms of 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.
4. To assess the effectiveness of the test products in terms of change hair fall from root test by 60 seconds hair combing test
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
5. To assess the effectiveness of the test products in terms of change in number of new hairs by using CASLite Nova
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
6. To assess the effectiveness of the test products in terms of change in hair regrowth by using CASLite Nova
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
7. To assess the effectiveness of the test products in terms of change in hair root strength by dermatological assessment
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
8. To assess the effectiveness of the test products in terms of change in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair oiliness, hair dryness and 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
9. To assess the effectiveness of the test products in terms of change in general appearance of scalp i.e. Itchiness, redness, roughness, and 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
10. To evaluate the effectiveness of the test products in terms of change in products perception questionnaire
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
11. To assess the effectiveness of the test products in terms of change in tensile strength of hairs
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 180
12.To evaluate the effect of test products in terms of change in nail brittleness
Baseline before usage of the test products on Day 01 and after usage of the test products on Day 180
13. To evaluate the effect of test products in terms of change in haematology i.e. CBC- haemoglobin, hematocrit, RBC, MCH, MCV, MCHC, WBC
Baseline before usage of test products on Day 01 and after usage of test products on Day 180.
14. To evaluate the effect of test products in terms of change in Biochemistry- SGOT, SGPT, serum creatinine, blood urea nitrogen (BUN), random blood sugar (RBS), PPBS, TC, TG, HDL, LDL, uric acid, VLDL
Baseline before usage of test products on Day 01 and after usage of test products on Day 180.
15. To evaluate the effect of test products in terms of change in testosterone, free testosterone, dihydrotestosterone
Baseline before usage of test products on Day 01 and after usage of test products on Day 180.
16.To evaluate the effect of test products in terms of change in CRP, random cortisol
Baseline before usage of test products on Day 01 and after usage of test products on Day 180.
17.To evaluate the effect of test products in terms of change in ferritin
Baseline before usage of test products on Day 01 and after usage of test products on Day 180
18.To evaluate the effect of test products in terms of change in urinalysis
Baseline before usage of test products on Day 01 and after usage of test products on Day 180 .
Target Sample Size
Total Sample Size="72" Sample Size from India="72" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
N/A
Date of First Enrollment (India)
09/08/2024
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief 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 Androgenic Alopecia (Grade I to III).
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.