| CTRI Number |
CTRI/2026/04/107296 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trial to Assess the Safety, Tolerability and Efficacy of the Baby Care Products. |
|
Scientific Title of Study
|
A Clinical Trial to Assess the Dermatological and Ophthalmological Safety, Tolerability and Efficacy of the Baby Care Products in Healthy Neonates, Babies and Young Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-MS-190 Version 1.0, dated 23 February 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohith HR |
| Designation |
Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
BGS Global Institute of Medical Sciences
No 67 BGS Health & Education City Uttarahalli Road Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
8792516793 |
| Fax |
|
| Email |
drrohith.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research No 9 1st Floor Mythri Legacy Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research No 9 1st Floor Mythri Legacy Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mother Sparsh Baby Care Pvt Ltd Plot 330 Industrial Area Phase 1 Panchkula Haryana 134113 India |
|
|
Primary Sponsor
|
| Name |
Mother Sparsh Baby Care Pvt. Ltd. |
| Address |
Plot 330 Industrial Area Phase 1 Panchkula Haryana 134113 India |
| Type of Sponsor |
Other [] |
|
|
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 Rohith H R |
BGS Global Institute of Medical Sciences |
Department of Research Room no 4 BGS Global Institute of Medical Sciences No 67 BGS Health & Education City Uttarahalli Road Kengeri
Bangalore
KARNATAKA |
8792516793
drrohith.research@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
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal hematological and biochemical parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baby Bathing Bar |
Apply to the face and whole-body during bath for 7 days. |
| Intervention |
Baby Powder |
Apply to the whole body and diaper area during diaper changes for 7 days. |
| Intervention |
Baby Shampoo |
Apply to the scalp during bath for 7 days. |
| Intervention |
Baby Wash |
Apply to the face and whole-body during bath for 7 days. |
| Intervention |
Baby Wet Wipes |
Apply to the face whole body and diaper area during diaper changes for 7 days. |
| Intervention |
Head-to-Toe Baby Wash |
Apply to the scalp, face and whole-body during bath for 7 days. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with all skin types (dry, normal, oily, combination, sensitive, and eczema-prone), as assessed by a dermatologist, and in good general health based on medical history and physical examination. 2. Subject wearing diaper at least for 12 hours per day. 3. Parent or legal representative (preferably the mother) provides written informed consent and agrees to attend follow-ups and comply with the study protocol. 4. Subject must not participate in any other clinical study during this study. |
|
| ExclusionCriteria |
| Details |
1.Subject above 6 years of age. 2. Subject with known allergy or chronic illness that may affect cutaneous assessment or require medical attention. 3. Subjects parent/legal representative not willing to stop use of other lotions during the study period, or the subject is on any systemic medication. 4. Subject with birth defects, chromosomal/metabolic anomalies, or significant dermatological diseases/conditions (e.g., atopy, psoriasis, vitiligo, porphyria, chronic urticaria, sunburn, rashes) that may alter skin appearance or physiological response. 5. Subject judged by the investigator to be inappropriate for this trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in overall scalp, hair, and skin condition, ocular safety assessed by parents, investigators, and ophthalmologist. |
Baseline and End of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the scores of safety and tolerability scales of test products by the investigator and also basis parent’s daily observation record. |
Baseline and End of Treatment |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/04/2026 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study evaluates the safety, tolerability, and efficacy of multiple baby care products in pediatric subjects. After obtaining informed consent from the parent or legal guardian, eligible subjects will be enrolled and randomized into study groups, with 35 subjects being randomized per groups. Each group will receive assigned investigational products in two test periods of 7 days each, separated by a 7 day washout period. Parents/guardians will apply the products as instructed and record compliance and observations in a subject diary. Safety and efficacy assessments will be conducted by the investigator, Pediatrician, Dermatologist, and Ophthalmologist. The total study duration for the clinical part shall be a maximum of 21 days per groups. |