Sensitization saftey of BTM Ventures Reginald Sunscreen

Not yet recruiting

Conditions: Not Applicable

Registration Number: CTRI/2025/04/084016

Lead Sponsor: Btm Ventures Pvt. Ltd.

Brief Summary: 200 human volunteers are selected for the patch test done as per BIS 4011 for sensitization

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

Guideline Followed: BIS 4011: for skin sensitization

1. BTM Ventures Reginal Sunscreen

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

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