Testing Bumsuit Baby Products to Check for Skin Irritation and Allergies in Healthy Children.

A Non-Randomized, Open-Label, Single-Center Study To Evaluate The Irritation And Sensitization Potential Of Bumsuit Baby Products In Healthy Volunteer Children Using The Human Repeat Insult Patch Test (HRIPT). - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/079932

Enrollment

Registered

2025-02-04

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 all

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers aged 5 to 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
Measured by visual assessment and scoring (e.g., Erythema, Edema) using a standardized grading scale at various time points during the induction phase.Timepoint: Day 0, Day 1, Day 2, Day 3 and Day 7, Day 14 and Day 21	—

Secondary

Measure	Time frame
Evaluated through participant-reported outcomes regarding skin discomfort, dryness, or other adverse effects through a standardized questionnaire.Timepoint: Day 0, Day 1, Day 2, Day 3 and Day 7, Day 14 and Day 21	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com09739001749

Outcome results