Skin Sensitization Activity of Marico Purite Baby 3 in 1 (Batch: TF010225)

Not yet recruiting

• Conditions: Not Applicable

• Registration Number: CTRI/2025/03/082331
• Lead Sponsor: MARICO SOUTH EAST ASIA CORPORATION

Brief Summary

210 human volunteers are selected for the patch test done as per ISO 10993 Part23 for sensitization

The experiment is 40 days including Induction phase: 21 days Rest Phase: 14 days Challenge Phase: 5 days.



Guideline Followed: ISO10993 Part 23: for skin sensitization



1. Purite Baby 3in1 (Batch: TF010225)

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Voluntary man or women between 18 and 65 years.
• Phototype III to V.
• Having apparently healthy skin on test area.
• For whom the investigator considers that the compliance will be correct.
• Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
• Having signed a Consent Form.
• Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
• Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study.
• Should be able to read and write (in English, Hindi or local language).
• Having valid proof of identity and age.

Exclusion Criteria

Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Skin Irritation Score-erythema & oedema	D2, D4, D6, D9, D11, D13, D16, D18, D20, D23,D24, D25

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

CCFT laboratories; 🇮🇳 Meerut, UTTAR PRADESH, India

CCFT laboratories

🇮🇳Meerut, UTTAR PRADESH, India

Dr Robin Chugh

Principal investigator

9027285265

robinderm25@gmail.com