| CTRI Number |
CTRI/2018/10/016138 [Registered on: 24/10/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study any untoward effects of a Lotion and body Wash in children with mild to moderate eczema (extreme dry skin), for a duration of 15 days |
|
Scientific Title of Study
|
Assessment of the in-use tolerance of a regime (The Moms Co. Natural Soothing Relief Lotion and The Moms Co. Natural Soothing Relief Wash) in children with mild to moderate eczema. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/073/0918/STU - Version: 1 of 14th September 2018 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Suneel Vartak |
| Designation |
Principal Investigator |
| Affiliation |
Skin Clinic |
| Address |
Flat No. 112, B-Wing, Rajan Complex, Above Annapurna Sweets, Datta Mandir Chowk, Nashik Road
Nashik
MAHARASHTRA
422101
India |
| Phone |
2466268 |
| Fax |
|
| Email |
suneel.vartak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nikunj Bali |
| Designation |
Manager-New Product Development |
| Affiliation |
Amishi Consumer Technologies Private Limited, |
| Address |
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 |
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 Suneel Vartak |
Skin Clinic |
Flat No. 112, B-Wing,
Rajan Complex, Above Annapurna Sweets,
Datta Mandir Chowk, Nashik Road - 422101
Nashik
MAHARASHTRA |
2466268
suneel.vartak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with mild to moderate eczema |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
The Moms Co Natural Soothing Relief Wash |
On wetting the body with water, apply approx. 0.5 gm of wash on entire body. Gently rub the wash and rinse it with running water. The product to be used twice a day for 15 days |
| Intervention |
The Moms Co. Natural Soothing Relief Lotion |
Apply the product liberally on affected sites gently using circular motion. The product to be applied 3 times a day for 15 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
With mild to moderate eczema.
|
|
| ExclusionCriteria |
| Details |
Chronic illness which may influence the study results.
Participants on medication for eczema.
Participants with drug induced dry skin.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Evaluation of affected sites
Assessment questionnaire for parents
Clinical evaluation for tolerance
|
Day 0
Day 15 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2018 |
| Date of Study Completion (India) |
03/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Conclusion The regime was very well tolerated. Based on clinical evaluation:
· There was a significant reduction in EASI scores indicating a significant improvement in eczema. · 100% participants showed a reduction in EASI Scoring indicating improvement in Eczema (reduction in redness, swelling, scratching and Lichenification). · 15% participants showed complete clearance of Eczema. · None of the participants had any erythema, oedema or roughness after 15 days of treatment. · 97.5 % of participants did not have any cutaneous dryness after 15 days of treatment. Based on parent questionnaire: · 100% of parents reported that there was a reduction in itching. · 77% of parents reported that there was a reduction in burning sensation · 67% of parents reported that there was a reduction in stinging. 100% of the parents reported a soothing effect after application of the products on the child.
|