| CTRI Number |
CTRI/2025/06/088779 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetic] |
| Study Design |
Other |
|
Public Title of Study
|
To check for skin irritation in Babies after bathing with a baby bathing bar. |
|
Scientific Title of Study
|
Evaluation of In-use Tolerance of Moisturex Baby Bathing Bar in babies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL/127/1124/STU Version No.: 1 of 06th January 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajiv Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD. |
| Address |
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 CTS No. 201 B/1, Western Express Highway, Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
43241234 |
| 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 |
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 CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai - 400 063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharmaceutical Industries Ltd. |
| Address |
Sun House CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai - 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 |
| Intervention |
Moisturex Baby Bathing Bar |
Body will be wet with water. The soap will be wet and rubbed
between palms to produce a lather, and lather will be applied on entire body of baby. Wash the
lather with water. Use at least once a day or more as per regular practice for a duration of 1 month. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
1. Apparently healthy babies in the age group: 3 months to 24 months.
2. Parents of babies agreeing to give feedback regarding product.
3. Parents of babies agreeing to use the Product as directed.
4. The parents are willing to provide written informed consent for babies to participate in the
study
5. Having valid proof of identity and age of babies. |
|
| ExclusionCriteria |
| Details |
1. Any kind of other skin diseases/conditions
2. Babies with atopic dermatitis
3. Presence of systemic illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical evaluation of skin for erythema and oedema using Draize scale. |
Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment questionnaire for parents for recording skin intolerances like redness, oedema, cutaneous dryness, roughness, itching. |
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/06/2025 |
| Date of Study Completion (India) |
19/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
Modification(s)
|
Immediately after birth, the skin barrier of healthy, full-term neonates is competent, yet skin- barrier function continues to develop through at least the first year of life. This developing state of infant skin results in infant skin being susceptible to dryness and irritation from external factors, such as cold weather and wind, as well as harsh topical skin-care products. Therefore, it is critical that infant cleansers and moisturizers be well tolerated and not disrupt the stratum corneum. Given the importance of the skin barrier in neonates and infants, it is important to use topical skin-care products that have undergone adequate skin-tolerance studies, yet there are very few published studies,evaluating the tolerability or efficacy of skin cleansers, lotions/emollients, and shampoos under real-world, normal conditions of use on healthy, full-term neonates or infants. In this study the in use tolerance of Product will be evaluated by use of Product on babies for a duration of 1 month, by clinical evaluation and parent feedback.
Result: The study was completed according to the protocol with 35 complete cases. |