safety of the test product to be checked

Completed

• Conditions: Healthy male and female participants

• Registration Number: CTRI/2023/11/059663
• Lead Sponsor: HNL Business Services India Private Limited

Brief Summary

The evaluationof substances for potential skin irritation and sensitization requires thoroughassessment before human testing. This assessment involves confirming the safetyof all ingredients based on existing research or alternative methods. Astandardized, repeatable patch testing procedure is essential to demonstratethe safe application of a material on human skin without significant risk ofadverse reactions. The Human Repeat Insult Patch Test (HRIPT) is the standardapproach for diagnosing contact allergies due to type IV hypersensitivity,involving repeated occlusive patch application for three weeks, followed by achallenge. The study design follows IS 4011:2018 guidelines and consists offour phases: induction, rest, challenge, and re-challenge. The objectivesinclude determining sensitization potential and cumulative irritation potentialthrough nine occlusive applications. The study involves 100 healthy subjects withvarious skin types, and screening ensures compliance with inclusion/exclusioncriteria and informed consent.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Study Completion: 2024-05-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Male or female subjects 18 to 65 years (both inclusive) of age.
• 2.Subjects with skin photo type III to V 3.Subjects must be generally in good health as determined from a recent medical history which is on file with the investigator.
• 4.The ability of the subject to understand and sign a written informed consent form which must be obtained prior to treatment.
• 5.Willingness to avoid UV exposure (sun or artificial UV) on the test sites during the course of the study.
• 6.Subjects must have clear back.
• They should not have any infection or allergy on the tested area.
• They should have healthy skin (Healthy skin is smooth, with no breaks in the surface.
• It is devoid of any rashes, scars, bumps etc.) on test area 7.Subjects should be cooperative, informed of the need and duration of the examination and ready to comply with the protocol procedures 8.Subjects having valid proof of identity and age.
• 9.Willingness to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study.

Exclusion Criteria

• 1.Pregnant women/ Nursing mothers 2.Presence of scars, excessive terminal hair or tattoo on the studied area.
• 3.Henna tattoo seen on the test site of the body.
• 4.Dermatological infection/pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systematic or cutaneous disease, which may interfere with study treatment or procedures, as evaluated by the study PI and co-PI.
• 7.Chronic illness which may influence the outcome of the study.
• 8.Subject 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.
• 10.Subjects having mole or hair on the back which may influence the study results as per the investigator and study coordinator decision 11.Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of the investigational products on healthy human subjects	Approximately 45 days for each subject

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1)

MS Clinical Research Pvt. Ltd; 🇮🇳 Bangalore, KARNATAKA, India

MS Clinical Research Pvt. Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Navya Annam

Principal investigator

08041125934

navya.annam@msclinical.com