| CTRI Number |
CTRI/2023/11/059467 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| 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 safety and efficacy of cosmetic product |
|
Scientific Title of Study
|
To evaluate the in-vivo safety and efficacy of Hair care formulation in terms of reduction in hair fall and improvement in hair growth (Hair Length) on healthy female subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I01-VZ-SR23; Version: Final 01; 18/10/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raji Patil |
| Designation |
Principal Investigator |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vansaar.Riaan wellness private limited, baidyanath Bhawan, 1 gupta lane, beside lohia hospital, Kolkata-700006 |
|
|
Primary Sponsor
|
| Name |
Vansaar |
| Address |
Riaan wellness private limited, baidyanath Bhawan, 1 gupta lane, beside lohia hospital, Kolkata-700006 |
| 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. |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
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 |
| Healthy Human Volunteers |
having moderate to severe hair fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Vansaar 45+ Maha Bhringraj Oil |
Approx. 3 ml of given product is to be applied on the whole head (Including Scalp and Hair shaft), thrice a week. for period of 28 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Indian female subjects.
2)Healthy subjects
3)Skin & scalp is healthy on the studied anatomic unit
4) Having moderate to severe hair fall |
|
| ExclusionCriteria |
| Details |
1)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
2) Having a progressive asthma (either under treatment or last fit in the last 2 years)
3) Being epileptic
4) Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
5) Having cutaneous hypersensitivity
6) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
7) 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)
8) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months
9) Having changed his/her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
10) Having applied a hair care product and cosmetic product on the studied area as well as on the face the first day of the study (except the neutral shampoo without anti hairfall claim or hair growth claim)
11)Having naturally fair or white hair (Which will interfere the evaluation)
12)Having a dermatosis on the scalp
13)Having surgery history on the scalp (micro transplants)
14)Refusing the bleaching of two areas of the scalp of approx. 40 hairs, the first day of the study.
15)Refusing the pluking of approx. 10 hairs, during the entire study
16)Having presented a factor inducing a telogen effluvium in the 3 months preceding the start of the study (delivery, important stress, high fever) |
|
|
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 and improvement in hair growth (Hair Length) |
Baseline, 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)
|
03/11/2023 |
| 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="4"
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 will be to evaluate the in-vivo safety and
efficacy of Hair care formulation in terms of reduction in hair fall and
improvement in hair growth (Hair Length) on healthy female subjects for
products
POPULATION
- 36 Female subjects will be selected for the study. The subjects selected for
this study are healthy females, aged between 40 and 55 years old having
moderate to severe hair fall,
DURATION
- 56 days including the 28 days of conditioning phase and 28 days of treatment
phase(For hair growth results obtained in treatment phase will be compared with
that of natural growth in conditioning phase)
STUDY
DESIGN - Single blind study.
The
evaluation is performed using- 1)Dermatological Evaluation: Safety 2)Measurement
of Hair Growth by Bleaching Technique 3)Counting of Fallen Hair after
Standardized Combing 4)Subject self evaluation |