| CTRI Number |
CTRI/2025/01/078896 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of the Efficacy and Safety of a Hair Care Formulation for Enhancing Hair Growth |
|
Scientific Title of Study
|
To evaluate the invivo efficacy and safety of hair care formulation in terms of hair growth ie improvement in AT ratio on healthy human subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-E9-OR24; Version: 01; Dated: 04/12/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
poojayadav@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eliea Wellness
1st floor, HOUSE NO 8,
Bishnu rabha nagar, Near Assam
jatia vidyalaya, Noonmati, Guwahati,
Kamrup Metropolitan, Assam 781020 |
|
|
Primary Sponsor
|
| Name |
Eliea Wellness |
| Address |
1st floor, HOUSE NO 8,
Bishnu rabha nagar, Near Assam
jatia vidyalaya, Noonmati, Guwahati,
Kamrup Metropolitan, Assam 781020 |
| Type of Sponsor |
Other [Non-government company ] |
|
|
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 Pooja Yadav |
Mascot Spincontrol India Pvt. Ltd. |
Sea Breeze Building, 9th Floor, Appasaheb Marathe Marg, Century Bazaar, Prabhadevi, Mumbai, Maharashtra
Mumbai
MAHARASHTRA |
02243349191
poojayadav@mascotspincontrol.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethos- An Institutional Ethics committee (Mumbai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
having different conditions of alopecia(L65.9 - Nonscarring hair loss, unspecified) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Test Product A |
Product to be applied on whole scalp and shaft, twice in a day for period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy male & female subjects in the age group of 18 to 45 years.
2)Subject is having valid proof of identity and age.
3)Subjects suffering from Alopecia.
4)Subjects with hair thinning based on visual /dermatological assessment.
5)Subjects having hair density between 100-150 per square centimeter |
|
| ExclusionCriteria |
| Details |
1)For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2)Having refused to give his/her assent by not signing the consent form
3)Taking part in another study liable to interfere with this study
4)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area
5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
6)Having a progressive asthma (either under treatment or last fit in the last 2 years)
7)Being epileptic
8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
9)Having cutaneous hypersensitivity
10)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
11)Following a chronic or intermittent medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
12)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair growth i.e. improvement in AT ratio |
Baseline, Day 7, Day 14 and Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2025 |
| Date of Study Completion (India) |
20/02/2025 |
| 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
|
OBJECTIVE: The objective of this study will be to evaluate
the in-vivo efficacy and safety of hair care formulation in terms of hair
growth i.e. improvement in AT ratio on healthy human subjects
The evaluation is performed using:Subject’s self-assessment
questionnaire, Dermatological evaluation: Cosmetic Acceptability, Phototrichogram
Analysis, Macro photographs of the Scalp & Hair Shaft
The study lasts 28 days following the first application of
the product.
POPULATION:36 (18 male and 18 female) subjects are selected
for the study.
The subjects selected for this study are healthy males &
females aged between 18 and 50 years old, having different conditions of
alopecia, presenting hair thinning basis visual /dermatological assessment
& having hair density between 100-150 per square centimeter.
STUDY DURATION: 28 days following the first
application of the product |