| CTRI Number |
CTRI/2025/02/081166 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of test products in healthy adult human male subjects having patchy beards and scalp hair fall complaints. |
|
Scientific Title of Study
|
A Clinical Study on the Safety, Efficacy, and In-Use Tolerability of Beard and Scalp Hair Growth Oils in Healthy Adult Males having patchy beards and scalp hair fall complaints |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240069-BI, 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Merja Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
917948983895 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub- Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481.
India |
| Phone |
9909013286 |
| 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 |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Marico Limited
Marks, Plot No: 23-C
Mahal Industrial Estate
Mahakali Caves Road
Andheri East, Mumbai 400093, India. |
|
|
Primary Sponsor
|
| Name |
Marico Limited |
| Address |
Marks, Plot No: 23-C
Mahal Industrial Estate
Mahakali Caves Road
Andheri East, Mumbai 400093, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
313, Silver Radiance-4, Gota - 382481
Ahmadabad
GUJARAT |
9909013286
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 |
| Healthy Human Volunteers |
Hair Fall Complaints and Patchy Beard |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blend of Coconut Oil and Mineral Oil |
Dose: 5-6 drops of oil
Dosage Form: Liquid
Mode of Usage: Take 5-6 drops of oil in the palm and rub it across the patch beard and hair scalp and gently massage it to enhance blood circulation. Leave the oil for 4 hours or overnight for better results.
Frequency: Three times a week (alternative days)
Duration: 90 Days
Route of Administration: Topical.
|
| Comparator Agent |
Nil |
NA |
| Intervention |
Oil with Herbal Active |
Dose: 5-6 drops of oil
Dosage Form: Liquid
Mode of Usage: Take 5-6 drops of oil in the palm and rub it across the patch beard and hair scalp and gently massage it to enhance blood circulation. Leave the oil for 4 hours or overnight for better results.
Frequency: Three times a week (alternative days)
Duration: 90 Days
Route of Administration: Topical.
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Age includes males having age of 21 to 30 years at the time of consent.
2) Subject are generally in good health.
3) Subjects with daily hair fall exceeding 100 strands/day and more than 25 strands falling during a 60-second hair combing test at the time of screening on Day -04.
4) Subject with patchy beards.
5) Subjects having normal dihydrotestosterone and free testosterone hormone levels during screening testing.
6) Subjects are willing to give written informed consent and are willing to follow the study procedure.
7) Subjects who commit not to use medicated/ prescription shampoos/hair care and beard related products (containing Minoxidil), any other hair or beard growth products or hair or beard colour or dye, other than the test products for the entire duration of the study.
8) Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1) History of any dermatological condition of the scalp (hair scalp and beard skin) other than hair loss.
2) History of prior use of hair growth or beard treatment within 3 months.
3) History of any prior hair growth or beard procedures ( hair transplant or laser).
4) Subjects who have applied topical treatment for hair or beard loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
5) Subject who perform any salon treatment on hair including haircut beard cutting during the study period.
6) History of alcohol or drug addiction.
7) Subjects using other marketed hair fall control and/or hair or beard growth products during the study period.
8) Subjects who have plans of shaving scalp and beard hair during the study.
9) Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
10) History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
11) Subjects having a history or present condition of an allergic response to any cosmetic products.
12) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
13) History of chronic illness which may influence the cutaneous state.
14) Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test products in terms of change in.
1. hair growth rate
2. hair density, hair thickness
3. patchy beard
4. number of hair follicles
5. hair shine
|
1. From baseline visit i.e., during Visit 01 (04 days before (Day 01) and Visit 02 (Day 01) before application and after products usage on Visit 03 (Day 18), Visit 04 (Day 21), Visit 05 (Day 42), Visit 06 (Day 45) and on Visit 07 (Day 87), Visit 08 (Day 90).
From baseline before test products usage on Day 01, and after test products usage on Day 21, Day 45, and Day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the absorption of the test products by the tissue absorbent test. |
after usage of the test products at T20 mins On Day 01 |
| To evaluate the effectiveness of the test products in terms of change in general appearance of the hair and scalp |
From baseline before test products usage on Day 01, and after test products usage on Day 21, Day 45, and Day 90 |
| To assess the effectiveness of the test products in terms of change in hair fall reduction. |
From baseline before test products usage on -04 before Day 01, and after test products usage on Day 21, Day 45, and Day 90 |
| To assess the effect of the test products in terms of products perception |
From baseline before test products usage on Day 01, and after usage of the test products on Day 21, Day 45, and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
22/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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, safety, efficacy and in-use tolerability of beard and scalp hair growth oils in Healthy Adult Males having patchy beards and scalp hair fall complaints. A total of 70 healthy adult male subjects (35 per arm) will be enrolled in the study. Potential participants will undergo screening based on the inclusion and exclusion criteria, following the provision of written informed consent.
Visit 01 (Day -04): ICD obtained, DHT, Free Testosterone, Screening, tattoo creation and hair growth rate measurement from beard and scalp. Visit 02 (Day 01): Enrolment, hair growth rate measurement, hair thickness, hair density, hair shine, 60 seconds hair comb test, digital photographs of beard, tissue absorbent test, general appearance of hair and scalp, number of hair follicles of beard patchy areas, patchy beard assessment, subject perception questionnaire, Dermatological assessment. Visit 03 [Day 18 (+2 Days)]: Tattoo creation and hair growth rate measurement from beard and scalp. Visit 04 Day 21: Hair growth rate measurement, hair thickness, hair density, hair shine, 60 seconds hair comb test, digital photographs of beard, tissue absorbent test, general appearance of hair and scalp, number of hair follicles of beard patchy areas, patchy beard assessment, subject perception questionnaire, Dermatological assessment. Visit 05 [Day 42 (+2 Days)]: Tattoo creation and hair growth rate measurement from beard and scalp. Visit 06 (Day 45 Days): Hair growth rate measurement, hair thickness, hair density, hair shine, 60 seconds hair comb test, digital photographs of beard, tissue absorbent test, general appearance of hair and scalp, number of hair follicles of beard patchy areas, patchy beard assessment, subject perception questionnaire, Dermatological assessment. Visit 07 [Day 87 (+2 Days)]: Tattoo creation and hair growth rate measurement from beard and scalp. Visit 08 [Day 90]: Hair growth rate measurement, hair thickness, hair density, hair shine, 60 seconds hair comb test, digital photographs of beard, tissue absorbent test, general appearance of hair and scalp, number of hair follicles of beard patchy areas, patchy beard assessment, subject perception questionnaire, Dermatological assessment, End of Study. |