| CTRI Number |
CTRI/2022/02/040653 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and efficacy assessment of Product on skin |
|
Scientific Title of Study
|
To evaluate the in-vivo efficacy and safety of a hair care formulation in terms of reduction in Hair Fall and Anti-dandruff effect on healthy male & female subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-7I05-KD-JR22; Version: Final 01; 08/02/2022 |
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban) MAHARASHTRA 400013 India
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 |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
raji@mascotspincontrol.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Mohit Lalvani |
| Designation |
Study Director |
| Affiliation |
MASCOT-SPINCONTROL India Pvt. Ltd. |
| Address |
Kohinoor Estate, 3rd Floor, Sun Mill Compound, Lower Parel West, Mumbai.
Mumbai (Suburban) MAHARASHTRA 400013 India
Mumbai
MAHARASHTRA
400013
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit@mascotspincontrol.in |
|
|
Source of Monetary or Material Support
|
| Mascot SpincontrolIndia pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Kama Ayurveda Pvt Ltd |
| Address |
3 K Commercial Circle, Jungpura Extension, New Delhi – 110014 |
| Type of Sponsor |
Other [Indian FMCG] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not applicable |
|
|
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 (Suburban) MAHARASHTRA
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 dandruff and hairfall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hair Oil 3: Product A |
Approx. 2-4 ml of given product is to be applied on scalp and hair shaft thrice a week. for period of 28 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Having moderate to severe hair fall.
2. Having Moderate to severe dandruff (where 0 is None, 1 is Slight, 2 is Mild, 3 is Moderate, 4
is Severe)
3. Suffering with hair thinning on subject assessment basis.
For female: Having at least shoulder length hair.
Having washed their hair with provided neutral shampoo, 48 hours before the first day of the
study with the provided nuetral shampoo.
Having untangled their hair at home, 3 hours prior coming to the site for observations, the first
day of the study. |
|
| ExclusionCriteria |
| Details |
1. Small, red bumps on the scalp, neck, and shoulders (bumps may become crusty and ooze).
2. Subject having applied a product with an anti-hair fall claim (due to breakage)or anti dandruff claim in the 2 weeks preceding the start of the study.
3. Having surgery history on the scalp (micro transplants …)
4. In the previous 6 months, Having undergone the Minoxidil treatments, Antiandrogen medicine (cyproterone acetate, spironolactone, flutamide), Having undergone one of the following treatments known to : induce hair loss : retinoids, anti coagulants, anti-convulsive drugs, chemotherapy, beta-blocking agents, non steroidal anti inflammatory drugs, corticoids,Having modified her hormonal contraception.
5. In the previous 3 months, Having undergone a local or general anti hair loss treatment (Biotine, dexpanthenol, sulphur amino-acid, B6 vitamin, zinc), Having taken a food supplement with an anti hair loss claim, Having taken an iron based treatment
6. In the previous 15 days, Having applied a product with an anti hair loss claim (due to breakage) or anti dandruff claim |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Hair Fall, Reduction in Anti-dandruff effect |
T0, 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety on skin |
T0, 14 days and 28 days |
|
|
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)
|
03/03/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 in-vivo safety and efficacy of hair care formulation in terms of reduction in Hair Fall and Anti-dandruff effect on healthy female & male subjects Duration of study: 35 days study (The study lasts 35 days including the 7 days conditioning phase and 28 days application period) Kinetics: Screening (T-7 days), T0, T+14 days and T+28 days Population: 36 (18 Females & 18 Males) volunteers The evaluation is performed using: 1. Subject’s Self Evaluation, 2. Dermatological Evaluation: Cosmetic Acceptability, 3. Dermatological Evaluation: Efficacy 4. Counting of fallen hair after standardized combing |