| CTRI Number |
CTRI/2025/02/080618 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The study to check the product safety and effectiveness |
|
Scientific Title of Study
|
To assess the safety and efficacy of Hair care formulation in terms of Anti dandruff effect |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A01-7I01-DD-JR25; Version: 01; Dated: 27/01/2025 |
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
|
| Onesto Labs Pvt. Ltd.
Plot No. 309, Sector 6, IMT Manesar,
Gurugram, Haryana (122052). |
|
|
Primary Sponsor
|
| Name |
Onesto Labs Pvt. Ltd. |
| Address |
Plot No. 309, Sector 6, IMT Manesar,
Gurugram, Haryana (122052). |
| 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 moderate to severe dandruff (L21.9, Seborrheic Dermatitis, unspecified) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
The Product is a regime with 3 Products, Bare Anatomy Expert Anti Dandruff Hair Tonic, Bare Anatomy Expert Anti Dandruff Shampoo, Bare Anatomy Expert Anti Dandruff Hair Mask |
All the Products are applied on the scalp and shaft, The Product Bare Anatomy Expert Anti Dandruff Hair Tonicis applied daily on whole scalp for the period of 42 days. The Product, Bare Anatomy Expert Anti Dandruff Shampoo is used to wash scalp and shaft twice in a week for the period of 42 days and the product Bare Anatomy Expert Anti Dandruff Hair Mask is applied on shafts once in a week for period of 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Indian male and female subjects.
2.Healthy subjects.
3.Skin is healthy on the studied anatomic unit
4.Having moderate to severe dandruff |
|
| ExclusionCriteria |
| Details |
1)Taking part in another study liable to interfere with this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anti-dandruff effect |
Baseline, Day 1, Day 7, Day 14, Day 28 and Day 42
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
24/02/2025 |
| 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="3"
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
|
OBJECTIVE: The aim of the study is to assess the safety and
efficacy of Hair care formulation in terms of Anti-dandruff effect.
The evaluation is performed using: Consumer Test - Self
Assessment Questionnaire
POPULATION: 60 males and 40 females’ subjects, aged between
18-35 years, having moderate to severe dandruff will be selected for this
study.
STUDY DURATION & KINETICS: The study will lasts for 42
days following the first application of the product.
Observations will be done on T0, T+1 days, T+7 days, T+14
days, T+28 days and T+42 days |