Testing the Safety of Bumsuit Baby Products for Skin Irritation and Allergies in Healthy Children

A Non Randomized, Open Label, Single Center Study to Evaluate the Irritation and Sensitization Potential of Baby Products in Healthy Volunteer Children using Primary Irritation Test. - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080659

Enrollment

Registered

2025-02-17

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
Measurement of local skin reactions such as erythema (redness), edema (swelling), dryness, or scaling at the application site after 24 hours. These will be scored using a standard irritation scoring scale.Timepoint: Day 0, Day 1, Day 2, Day 3 and Day 7	—

Secondary

Measure	Time frame
Observation of any signs of allergic sensitization, such as delayed erythema, papules, or vesicles, occurring post-24-hour patch removal and in subsequent follow-ups. Sensitization will be scored and categorized based on the intensity of reactions.Timepoint: Day 0, Day 1, Day 2, Day 3 and Day 7	—

Countries

India

Contacts

Public ContactMs Arpita Malgi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results