| CTRI Number |
CTRI/2024/10/074728 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceuitcal] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Assessment of safety and efficacy of product on human volunteers |
|
Scientific Title of Study
|
Evaluation of safety and efficacy of Roll on in reducing sweat, sweat malodor, axillary pigmentation and enhancing skin moisturization |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XXX-XH02-ZC-JY24; Version: 01; Dated: 30/08/2024 |
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
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
Mumbai
MAHARASHTRA
400025
India |
| Phone |
02243349191 |
| Fax |
|
| Email |
mohit.CTRI@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC LIMITED
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA |
|
|
Primary Sponsor
|
| Name |
ITC LIMITED |
| Address |
ITC Life Sciences and Technology Centre,
No. 3, 1st Main Road,
Peenya Industrial Area, I Phase Peenya,
Bangalore – 560058, INDIA |
| Type of Sponsor |
Other [Fast-Moving Consumer Goods] |
|
|
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 body odor, excessive sweating issues, axillary
hyperpigmentation / darkness and varied skin types. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product B |
Product is applied on one randomized underarm. once in a day for period of 3 days. |
| Intervention |
Roll On - Product A |
Product is applied on one randomized underarm. once in a day for period of 3 days. |
| Comparator Agent |
Untreated site |
Another underarm is served as untreated control site. No product application is carried out on this site |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy subjects
2)Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
3)Having mild to moderate malodour.
4)Having sweat and visible underarm pigmentation
5)Having shaved under arms two days before each study visit.
6)Having mild to moderate axillary odour and whose left vs right axillary odour levels are more or less the same.
7)Subjects representing varied skin
8)Exhibiting good tolerance to the investigational product with no signs of sensitivity.
|
|
| ExclusionCriteria |
| Details |
1)For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past
three months.
2) Having refused to give assent by not signing the consent form
3) Taking part in another study liable to interfere with this study
4) Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy
(less than 6 months)
5) Having a progressive asthma.
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.
11) 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)
and/or smoked in the two hours preceding the measurements
12) Having undergone a surgery requiring a general anaesthetic of more than one hour in the past
6 months.
13) Having changed her cosmetic habits in the 14 days preceding the start of the study on the
studied anatomic unit
14) Having applied a cosmetic product (included make-up) or skin care product on the studied
areas the day of the study (only face cleaned with water is accepted) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Controlling Sweat and Sweat malodor |
Baseline, Immediate after application, 8Hours, 24 hours, Day 3, Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reducing Axillary hyperpigmentation and enhancing skin
Moisturization |
Baseline, Immediate after application, 8Hours, 24 hours, Day 3, Day 6 |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2024 |
| Date of Study Completion (India) |
20/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Study Population: About 72 healthy human adult volunteers of either gender in the age grp of 19y to 45y, will be enrolled for studying the sweat and sweat odor controlling efficacy of test products.
Study duration: 13 days, 7 days of conditioning phase and 3 days of product intervention phase and 3 additional days of observation.
Assessments: Instrumental measurement of sweat, skin hydration, Color. Sensory assessment of skin condition, sweat and related odor. |