| CTRI Number |
CTRI/2025/02/080296 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Cumulative Irritation Patch Test - Bumsuit Baby Cream, Lotion, Massage Oil and Shampoo.] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Skin Irritation and Sensitization Potential of Bumsuit Baby Products in Children Using a Patch Test |
|
Scientific Title of Study
|
A Non Randomized, Open Label, Single Center Study To Evaluate The Irritation And Sensitization Potential Of Bumsuit Baby Products In Healthy Volunteer Children Using Cumulative Irritation Patch Test.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2428 Version No. 1.0 Dated 12/Dec/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Kumar S |
| Designation |
Principal Investigator |
| Affiliation |
Currex Hospital Bangalore |
| Address |
No.55-56, Seegehalli Main Road, Bhoo Samartha Layout,
Bangalore
KARNATAKA
560059
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
pi.clinicaltrial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit No.1204, Ashva, 2nd Floor, 26th Main,
Jayanagar 9th Block, Bangalore
Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Kamson Healthcare Pvt. Ltd.
Sy.No 546,AA1,AA2, Nandigam
(Village & Mandal) Rangareddy Dist., Telangana, India -509228 |
|
|
Primary Sponsor
|
| Name |
Kamson Healthcare Pvt. Ltd. |
| Address |
Sy.No 546,AA1,AA2, Nandigam
(Village & Mandal) Rangareddy Dist., Telangana, India -509228 |
| 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 Uday Kumar S |
Currex Hospital |
No.55-56, Seegehalli Main Road, Bhoo Samartha Layout,
Seegehalli, KS Halli, Bengaluru
Bangalore
KARNATAKA |
06364898825
pi.clinicaltrial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To Evaluate The Irritation And Sensitization Potential of Bumsuit Baby Products In Healthy Volunteer Children Using Cumulative Irritation Patch Test. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bumsuit Baby Cream,
Bumsuit Baby Lotion,
Bumsuit Baby Massage Oil, and Bumsuit Baby Shampoo |
The products will be applied in a patch chamber (0.04 ml) to evaluate skin irritancy and allergic sensitization. The duration of treatment will be 24 hours, with a one-hour window, for a period of 14 days (with an additional one-day window). |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy volunteers aged 5-18 years.
2. Subjects with no clinically significant dermatological conditions (e.g., eczema, psoriasis).
3. Subjects whose guardians/parents have provided Informed Consent.
4. Willing to adhere to study restrictions (no use of other skincare products in the test area).
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of the total irritation score based on skin reactions observed at each application site after each patch application throughout the study period. This score will be calculated based on a standardized irritation assessment scale. |
Day-0, Day-1, Day-2, Day-3, Day-7 and Day-14. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of any delayed hypersensitivity reactions, such as allergic contact dermatitis, occurring after repeated applications based on specific scoring criteria. |
Day-0, Day-1, Day-2, Day-3, Day-7 and Day-14 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2025 |
| Date of Study Completion (India) |
05/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
|
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)
|
Background and Introduction The early stages of life were recognized as critical for the healthy development of children, and proper skincare played an essential role in promoting long-term well-being. During childhood and adolescence, the skin underwent various changes; therefore, skincare products needed to be both effective and safe. Baby products, commonly used to moisturize and protect the skin, had to be carefully evaluated to ensure they did not cause irritation or sensitization, particularly in children and adolescents, whose skin was often more sensitive than that of adults. The study participants, representing a wide range of skin types, helped determine whether the products were suitable for use in children and adolescents. This research provided essential data to confirm the safety profile of the baby products, ensuring they met safety standards and could be used confidently by parents, caregivers, and healthcare professionals. Purpose of the Study The purpose of the study was to evaluate the safety and suitability of baby skincare products for children and adolescents, considering their sensitive skin and varying skin types. The research aimed to confirm that these products were non-irritating, did not cause sensitization, and met established safety standards. The data obtained provided confidence to parents, caregivers, and healthcare professionals in using these products to support the healthy development and well-being of young individuals. Results The study was conducted over a 14-day period and included 24 healthy children aged between 5 and 18 years, all of whom completed the study. The average age of the participants was 11.5 years. Four baby care products Bumsuit Baby Cream, Lotion, Massage Oil, and Shampoo were evaluated for their irritation and sensitization potential. Primary Endpoint (Irritation Assessment using Draize Scale):
All 24 subjects showed no signs of erythema, edema, dryness, or peeling throughout the 14-day application period.
No irritation reactions were observed at any time point. Secondary Endpoint (Sensitization / Subject Self-Assessment):
100% of participants reported no burning, itching, tingling, erythema, or scaling.
No delayed hypersensitivity reactions or allergic responses were observed. Adverse Events (AEs/SAEs):
No adverse events or serious adverse events were reported.
No protocol deviations occurred.
The compliance rate was 100%.
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