| CTRI Number |
CTRI/2018/07/014740 [Registered on: 05/07/2018] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of 2 products on skin moisturisation over duration of 24 hours |
|
Scientific Title of Study
|
Evaluation of skin hydration, after application, of 2 test products, on volar forearms, over duration of 24 hours |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/031/0618/STU |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
C.L.A.I.M.S. PVT. LTD |
| Address |
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate, New Link Road,
Andheri (W), Mumbai - 400058
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate, New Link Road,
Andheri (W), Mumbai - 400058
Mumbai
MAHARASHTRA
Dr Rajiv Joshi
India |
| Phone |
2266758851 |
| Fax |
|
| Email |
rsjdr@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nikunj Bali |
| Designation |
Manager-New Product Development |
| Affiliation |
Amishi Consumer Technologies Private Limited, |
| Address |
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
New Delhi
DELHI
110013
India |
| Phone |
08800712526 |
| Fax |
|
| Email |
nikunj.bali@themomsco.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nikunj Bali |
| Designation |
Manager-New Product Development |
| Affiliation |
Amishi Consumer Technologies Private Limited, |
| Address |
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
Amishi Consumer Technologies Private Limited,
1982/9, FF, Chuna Mandi,
Paharganj, New Delhi, India - 110013
Bhandara
DELHI
110013
India |
| Phone |
08800712526 |
| Fax |
|
| Email |
nikunj.bali@themomsco.com |
|
|
Source of Monetary or Material Support
|
| Amishi Consumer Technologies Private Limited,
1982/9, FF, CHUNA MANDI, PAHARGANJ, NEW DELHI, INDIA - 110013 |
|
|
Primary Sponsor
|
| Name |
Amishi Consumer Technologies Private Limited |
| Address |
1982/9, FF, CHUNA MANDI, PAHARGANJ, NEW DELHI, INDIA - 110013 |
| 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 Rajiv Joshi |
C.L.A.I.M.S. PVT.LTD |
4th Floor, B wing, Modi House,
C-10, Dalia Industrial Estate, New Link Road,
Andheri (W), Mumbai - 400058
Mumbai
MAHARASHTRA |
2266758851
rsjdr@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Dry skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
The Moms Co Body Butter |
Approximately 0.030 g of the products will be applied |
| Intervention |
The Moms Co Natural Soothing Relief Lotion |
Approximately 0.030 g of the products will be applied |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Dry skin type
Cooperating informed of the need and duration of the examinations. |
|
| ExclusionCriteria |
| Details |
Menopausal/Pregnant women by taking history, Lactating mothers.
Any cutaneous conditions on test site (scars, moles, papules etc).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hydration measurements using MMSC |
0 hour (before product application), 4 hours, 8 hours, 12 hours and 24 hours after product application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of skin tolerance |
0 hour (before product application), 4 hours, 8 hours, 12 hours and 24 hours after product application |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/07/2018 |
| Date of Study Completion (India) |
26/07/2018 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
After 24 hours of Product application,
Instrumental evaluation The Moms Co. Natural Soothing Relief Lotion (B. No: R107290618) and The Moms Co. Natural Body Butter (B. No: MBB-35), were efficacious in significantly moisturizing the skin for 24 hours as compared to baseline. Skin Moisturization was significantly more with The Moms Co. Natural Soothing Relief Lotion (B. No: R107290618) as compared to The Moms Co. Natural Body Butter (B. No: MBB-35)
Clinical examination The Moms Co. Natural Body Butter (B. No: MBB-35) and The Moms Co. Natural Soothing Relief Lotion (B. No: R107290618) were very well tolerated by all participants. |