| CTRI Number |
CTRI/2024/08/072061 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of product on hair thickness and hair fall |
|
Scientific Title of Study
|
To evaluate in vivo safety and efficacy of hair care formulation in terms of improvement in hair thickness and reduction in hair fall on healthy human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I03-PI-JY24; Version: 01; Dated: 16/07/20234 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Yadav |
| Designation |
Principal Investigator |
| Affiliation |
Mascot Spincontrol Pvt Ltd |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India
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 Pvt Ltd |
| Address |
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India
Mumbai
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 400025, INDIA
Mumbai
MAHARASHTRA
400025
India
Sea Breeze Building, 9th Floor, AppaSaheb Marathe Marg, Century Bazaar, Prabhadevi,
Mumbai, Maharashtra 400025, INDIA
Mumbai
MAHARASHTRA
400025
India
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurved Limited,
Unit III-Patanjali Food & Herbal Park,
Vill-Padartha, Haridwar-Laksar Road,
Haridwar-249404, Uttarakhand, India. |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved Limited |
| Address |
Unit III Patanjali Food & Herbal Park Vill Padartha Haridwar Laksar Road Haridwar 249404 Uttarakhand India |
| Type of Sponsor |
Other [FMCG] |
|
|
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 mild to moderate
hair fall & dull and dry hair with split ends |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kera –Smooth Hair Mask (Hair Thinning Expert) |
Product is applied on whole head, twice a week for a period of 84 days. |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian female subjects
2. Healthy subjects
3. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4. Having mild to moderate hair fall
5. Having dull and dry hair with split ends |
|
| ExclusionCriteria |
| Details |
1. For female: 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 study4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5. Having a progressive asthma (either under treatment or last fit in the last 2 years)
6. Being epileptic.
7. Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
8. Having cutaneous hypersensitivity
9. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
10. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
11. 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 |
| improvement in hair thickness and reduction in hair fall |
Baseline, Day 28, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
11/08/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The objective of this study will be to evaluate in
vivo safety and efficacy of hair care formulation in terms of improvement in
hair thickness and reduction in hair fall on healthy human subjects.
The evaluation is performed using: Subject Self
Evaluation, Dermatological Evaluation: Cosmetic Acceptability,
Corneometry, Analysis of hair thickness through Dino-lite Digital
Microscope and Counting of Fallen Hair after Standardized Combing.
The study last 84 days following the first application
of the product.
POPULATION: 36 (18 male and 18 female) subjects
will be selected for the study.
The subjects selected for this study are healthy males
& females aged between 18 and 35 years having mild to moderate hair fall
& dull and dry hair with split ends
|