Evaluation of Skin Irritation and Sensitization Potential of Bumsuit Baby Products in Children Using a Patch Test

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. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080296

Enrollment

Registered

2025-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 a

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Day-0, Day-1, Day-2, Day-3, Day-7 and Day-14.	—

Secondary

Measure	Time frame
Evaluation of any delayed hypersensitivity reactions, such as allergic contact dermatitis, occurring after repeated applications based on specific scoring criteria.Timepoint: Day-0, Day-1, Day-2, Day-3, Day-7 and Day-14	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results