Skin irritation test on Biyur Organics Hair oil on healthy human subjects.

Recruiting

Brief Summary: **The below products would be tested as per the guideline IS4011 for dermal safety assessme****nt.**

1. Biyur Organics Hair Oil

The product will be tested for skin irritation on 24 human volunteers.

Assessment would be done on day 0, day 1, with followup visit on day 8 for erythema and Oedema scoring.

Study is done as per BIS standard 4011

Recruitment & Eligibility

Inclusion Criteria

Voluntary male/women between 18 and 65 years.
Photo type III to V.
Having apparently healthy skin on test area 4.
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, saunaâ€¦), 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/nursing mothers 2.
Scars, excessive terminal hair or tattoo on the studied area.
Henna tattoo anywhere on the body (in case of studies involving hair dyes).
Dermatological infection/pathology on the level of studied area.
Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
Chronic illness which may influence the outcome of the study.
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).
Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.

Primary Outcome Measures

Name	Time	Method
Change in Skin Irritation Score-erythema & oedema	Day 1, Day2 , Day8

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Locations (1): CCFT laboratories
🇮🇳
Meerut, UTTAR PRADESH, India
CCFT laboratories
🇮🇳Meerut, UTTAR PRADESH, India
Dr Robin Chugh
Principal investigator
7078103723
robinderm25@gmail.com