| CTRI Number |
CTRI/2024/08/071885 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
An exploratory clinical study to assess Safety, Efficacy and In-Use tolerability of three different hair growth products in patients with mild to moderate androgenic alopecia (Grade I to III). |
|
Scientific Title of Study
|
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). |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NB240029-ZV Version 3.0 07Aug25 |
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
|
|
|
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 |
7948983895
dr.nayan@novobliss.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS– Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
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 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
Route of administration: Topical
Total Duration: 180 Days |
| Intervention |
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.
Dose: small amount or as required
Dosage form: liquid
frequency: Daily night application
Route of administration: Topical
Total Duration: 180 Days |
| Intervention |
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
Route of administration: Topical
Total Duration: 180 Days |
| Intervention |
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.
Dose: small amount or as required
Dosage form: liquid
frequency: Daily night application
Route of administration: Topical
Total Duration: 180 Days |
| Intervention |
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.
Dose: small amount or as required
Dosage form: liquid
frequency: Daily night application
Route of administration: Topical
Total Duration: 180 Days |
| Intervention |
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
Route 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
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) 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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
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, on Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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) |
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 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 |
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 |
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 |
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 |
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 |
To assess the effectiveness of the test products in terms of change in hair
strength from root 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 |
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 |
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 |
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 |
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. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 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. 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 screeing visit 2 enrollment baseline evaluation visit 3 product phase and evaluation visit 4 tattoo creation and evaluation visit 5 evaluations visit 6 evaluations visit 7 tattoo creation and evaluation visit 8 evaluation |