| CTRI Number |
CTRI/2025/05/086158 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Safety and Effectiveness of a Hair Growth Serum in People with Mild to Moderate Androgenic Alopecia (Grades I–III). |
|
Scientific Title of Study
|
A Single-Arm, Single-centre, Study Evaluate the Safety and Efficacy of a Hair Growth Serum in Patients with Mild to Moderate Androgenic Alopecia (Grades I–III). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250015-OL_1.0_17Apr25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshwari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| OneSto Labs Private Ltd.
Plot no. 309, Sector 6,
IMT Manesar, Gurugram,
Haryana 122052 |
|
|
Primary Sponsor
|
| Name |
OneSto Labs Private Ltd. |
| Address |
Plot no. 309, Sector 6,
IMT Manesar, Gurugram,
Haryana 122052
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
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 Private Limited |
Clinical Trial Department NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmedabad, Gujarat, India - 382481.
Gandhinagar
GUJARAT
382421
India
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| 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
|
| Type |
Name |
Details |
| Intervention |
Hair growth Serum |
Mfg by: OneSto lab private Ltd.Mode of Usage: Apply a small amount of serum directly to your fingertips and massage gently into the scalp and roots using circular motions in order to ensure even absorption and distribution. Repeat this process on your entire scalp, concentrating most on areas of need. Avoid washing the serum out; instead, allow it to absorb fully.
Note: This is a leave-in treatment, there is no need to wash your hair after applying it.
Frequency: Daily Night application.
Rout of administration: Topical
Duration: 120 Days
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18-55 years (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, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
11) Willing to use test treatment throughout the study period.
12) Subject is willing and able to follow and allow study staff to perform 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) Subjects 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test treatment in terms of change in
1. hair growth (in terms of hair length)
2. hair thickness and hair density |
Day 01, Day 40, Day 80 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test treatment in terms of change in
1. Change in A: T
2. change in hair fall
3. change in general appearance of hair
4. change in general appearance of scalp skin.
5. improvement in hairline and bald patches
6. product perception questionnaire |
Day 01, Day 40, Day 80 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
12/05/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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, single- arm, single- centre, open -label, clinical safety and efficacy study of hair growth serum in the patients with mild to moderate AGA (Grade I-III) A total of 32 subjects with an age of 18-55 years of age will be enrolled to complete 30 subjects of the study. subjects will be instructed to visit the facility as per below visit: Visit 01 (Day 01): Screening, Enrolment, baseline evaluation Visit 02 (Day 40): Treatment usage period, and Evaluation Visit
|