| CTRI Number |
CTRI/2025/04/084280 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To study skin hydration at 12 hours and 24 hours after applying lotion in babies. |
|
Scientific Title of Study
|
Evaluation of moisturizing effect of Moisturex Baby Moisturizing Lotion in babies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/136/1224/STU Version No.: 1.1 of 26th February 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator - Consultant Dermatologist |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
rsjdrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavesh Lalan |
| Designation |
Senior Manager - Medical Affairs |
| Affiliation |
Sun Pharmaceuticals Industries Ltd |
| Address |
Sun House, Plot No. 201 B/1
Western Express Highway, Goregaon (East)
Mumbai
MAHARASHTRA
400 063
India |
| Phone |
7276309223 |
| Fax |
|
| Email |
bhavesh.lalan@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Preetha Paul |
| Designation |
Senior Manager - TQM |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
66758851 |
| Fax |
|
| Email |
preetha@claimsclinical.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharmaceutical Industries Ltd. Sun House, Plot No. 201 B/1 Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India), 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House, Plot No. 201 B/1 Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India). 400 063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.) |
502, 5th Floor, 27 MIDC Commercial Premises, 17th Road, MIDC, Andheri East
Mumbai
MAHARASHTRA |
66758851
rsjdrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLAIMS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy babies with healthy skin will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control site |
No product will be applied on control site for a duration of 24 hours. |
| Intervention |
Moisturex Baby Moisturizing Lotion |
At Day 1, the test sites (identified site on legs) will be cleaned, and babies will be
acclimatized under controlled conditions of temperature (20-22 o C) and humidity (40-
60%) for 30 minutes. One site will be marked on one leg for test product and one
site on other leg which will be untreated control.
Baseline readings will be
taken at test and control site.
Product will be applied on test sites by study staff as instructed.
Product will be kept on skin for a duration of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
1. Healthy babies with dry skin and/or normal skin determined clinically.
2. Between 3 months and 24 months of age.
3. Parents accepting not to use products with the same end benefit on babies during the entire
study duration.
4. Parents cooperating, informed of the need and duration of the examinations, and ready to
comply with protocol procedures.
5. Parents having signed a Consent Form after being informed orally and in writing of all
information concerning the study procedures and study objectives. |
|
| ExclusionCriteria |
| Details |
1. Skin allergy antecedents or atopic subject.
2. Hypersensitivity to any cosmetic product, raw material.
3. Any clinically significant systemic or cutaneous disease, which may interfere with study
procedures.
4. Babies on any medical treatment either systemic or topical which may interfere with the
performance of the study (presently or in the past 1 month). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Skin Hydration using MoistureMeter SC after product application.
|
12 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Skin Hydration using MoistureMeter SC at 24 hours after product application
2.TEWL measurements using VapoMeter at 12 hours and 24 hours after product application.
3. Clinical evaluation for skin tolerance (erythema and oedema), using Draize scale after product application |
12 hour, 24 hour |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
07/04/2025 |
| 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="1"
Months="0"
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
|
The test product is a moisturizing lotion. Moisturizers, or emollients, are chemical mixtures designed to soften and make the skin more pliable. They function as occlusives (e.g., petrolatum, waxes), humectants (e.g., glycerin, urea), or emollients (smoothen skin by filling spaces between flakes with oil). This study aims to evaluate the lotion’s moisturizing effect on babies’ skin and check for any irritation post-application. |