| CTRI Number |
CTRI/2024/03/064647 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of safety and efficacy of product |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of hair care formulation in terms of reduction in hair fall effect on human subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-UW-FR24; Version: 01; Dated:24/02/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| BEAUTY GARAGE INDIA PVT. LTD. Ground Floor, Plot No.17, Road No.9, Marol Industrial Area, Behind Tunga Paradise Hotel, MIDC,Andheri (E), Mumbai-400 093 |
|
|
Primary Sponsor
|
| Name |
BEAUTY GARAGE INDIA PVT. LTD. |
| Address |
Ground Floor, Plot No.17, Road No.9, Marol Industrial Area, Behind Tunga Paradise Hotel, MIDC,Andheri (E), Mumbai-400 093 |
| 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 Raji Patil |
Mascot Spincontrol India Pvt. Ltd. |
Mascot Spincontrol India Pvt. Ltd. Kohinoor Estate, 3rd Floor Sun Mill Compound, Lower Parel
Mumbai
MAHARASHTRA |
02243349191
raji@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 |
| Patients |
(1) ICD-10 Condition: L659||Nonscarring hair loss, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Regime with Beauty Garage Scalp
Sense Soothing Shampoo, Beauty Garage Scalp Sense Intense Scalp Clear Treatment, Beauty Garage Scalp Sense Dandruff Defence Scalp Vaccine Treatment Conditioner, Beauty Garage Scalp Sense Hydra Soothe Scalp Vaccine Treatment Conditioner, Beauty Garage Scalp Sense Soothing Hair and Scalp Conditioner, Beauty Garage Scalp Sense Dandruff Defence Shampoo, Beauty Garage Scalp Sense Folicare Scalp leave In Treatment |
It is a Regime. The products are applied on whole scalp and shafts , for a period of 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Asian Indian humans subjects.
2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable
and stop the study, no pathology which could interfere with the study, no symptom in the process
of an exploratory checkup)
3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
4.Having oily scalp and moderate to severe hair fall |
|
| ExclusionCriteria |
| Details |
1.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.Following a chronic or intermittent medicinal treatment comprising any of the following products
: aspirin-based products, anti-inflammatories, anti-histamines, anti-coagulants, 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
12.Having changed her cosmetic habits except those mentioned in protocol in the 7 days preceding
the start of the study on the studied anatomic unit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in hair fall, Safety |
Baseline, 14 days, 28 days |
|
|
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)
|
30/03/2024 |
| 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="2"
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 objective of this study is to evaluate the in-vivo efficacy and safety of hair care formulation in terms of reduction in hair fall effect on human subjects.
Population:36 (18 Females and 18 Males) subjects will be selected for the study.
The subjects selected for this study will be healthy male and females aged between 18 and 35 years, having oily scalp and moderate to severe hair fall..
Study timepoints: Baseline, T+14 Days, T+28 Days The evaluation is performed using: Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Counting of fallen hair after standardized combing, Sebumetry |