Safety testing of cosmetic products by PIPT(Primary Irritation Patch Test)

Completed

• Conditions: Adult healthy subject (male and female) in theage group of 18 years to 55 years (bothinclusive) will be selected

• Registration Number: CTRI/2022/02/039947
• Lead Sponsor: Arbro pharmaceutical Pvt Ltd

Brief Summary

Objective:

The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjects. A primary irritation patch test is used widely for the evaluation of the safety of cosmetics in humans.



Sample Size: Twenty four (male and female, in a nearly equal ratio of 1:1) adult subjects in the age group of 18 years to 55 years (both inclusive)



Primary skin irritation results from reversible inflammatory changes in the skin following the application of a test substance.



By this test, irritation potential of a substance is assessed by a single application of patch under complete occlusion for 24 hrs and is done as per BIS standard (BIS4011:2018)

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-18
• Last Update Posted: 2022-05-04
• Study Start: 2022-07-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1.Healthy male and female subjects in the age group of 18-55 years(both age inclusive) 2.
• Subject is having valid proof of identity and age 3.
• Subjects with skin phototype III to V 4.Subject is having apparently healthy skin on test area 5.Subject representing normal, oily, dry and combination skin type in nearly equal ratio 6.
• Subject willing to give a voluntary written informed consent 7.
• Subject willing to maintain the test patches in designated positions for 24 Hours 8.
• Subject willing to come for regular follow up visits 9.
• Subject ready to follow instructions during the study period 10.
• Subject without any open wounds, cuts, abrasions, irritation symptoms.

Exclusion Criteria

• Subjects with Known hypersensitivity to any of the study products or constituents 2.
• Subjects having any significant pathology in the test area 3.
• Subjects with any kind of skin allergy, antecedents or cutaneous disease which may influence the study results 4.
• Subjects having topical or systemic treatment in last month prior to participation in the study and during the study that could interfere with the study treatments/ assessments 5.
• Athletes and subjects with history of excessive sweating 6.
• Subject is Pregnant or Lactating 7.
• Subject with any significant medical condition that would interfere with the participation in the trial 8.
• Subjects participated in any other cosmetic or therapeutic trial or in a similar investigation 9.
• Subject is having Scars, excessive terminal hair or tattoo on the studied area.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety assessment of investigational products for	Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
irritation potential using Draize scale after patch	Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
removal at 0 hours(day 3),24 hours(day 4) and 7 days post	Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.
patch removal.	Safety assessment of investigational products for | irritation potential using Draize scale after patch | removal at day 3, day 4 and 7 days post patch removal.

Trial Locations

Locations (1)

Auriga Research Pvt. Ltd.; 🇮🇳 Gurgaon, HARYANA, India

Auriga Research Pvt. Ltd.

🇮🇳Gurgaon, HARYANA, India

Dr Pooja Aggarwal

Principal investigator

0124006445

dr.poojaggarwal@gmail.com