to check saftey of investigational products through primary irritation patch test

Completed

• Conditions: not applicable

• Registration Number: CTRI/2018/04/013057
• Lead Sponsor: TTK Protective Devices Limited

Brief Summary

Single Application Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.

**Objective : To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers .**

**Duration of study: 8 days study**

**Kinetics: T0 (**Patch application)**,****T1(**Patch removal**), T2(**Evaluation of test sitesby Dermat post 24 hrs of  patch removal**), T8 (**Evaluation of test sitesby Dermat post 1 week of patch removal and tracking the positive cases**)**

**Population 26 healthy subjects(13 males + 13 females)**

**Products :** Lubes- Warming (MNWL-026) , Lubes -Strawberry (MNFL-016) , Lubes - Cherry (MNFL-019) , Lubes - Cool – Banana( MNCL-021) , Lubes - Cool - Mint (MNCL-024) **Positive control: 3% SLS**

**Negative control: Distilled water**

**The test area is checked for erythema and oedema caused due to the products and**

**compared with positive control**

**products were non irritant to skin**

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Study Completion: 2017-10-18
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).

Exclusion Criteria

For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, psoriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the dermatological safety of	T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up
investigational products by primary irritation	T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up
patch test on healthy human volunteers	T0- baseline | T1-patch removal | T2- dermat grading | T8- follow up

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

MASCOT-SPINCONTROL India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

MASCOT-SPINCONTROL India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Siddheshwar Mathpati

Principal investigator

022-43349191

siddheshwar@mascotspincontrol.in