To know the safety of Investigational products by assessing the irritation after patch application onhealthy human volunteers

Completed

• Conditions: Normal

• Registration Number: CTRI/2013/03/003459
• Lead Sponsor: ITC RD CENTRE

Brief Summary

Single Application Closed Patch Test is conducted to measure the irritation potential of cosmetic products on the skin.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

**Objective : To evaluate the dermatological safety of investigational products by primary**

**irritation patch test on healthy human volunteers of varied skin types.**

**Duration of study: 8 days study**

**Kinetics: T0 (**Evaluation of test sites by Dermat and Subject,

Patch application)**, T1(**Patch removal - 30 minutes acclimatization, Evaluation of test sites by Dermat and Subject post 30 minutes of patch removal**), T2(**Evaluation of test sitesby Dermat and Subject post 24 hrs of  patch removal**), T8 (**Evaluation of test sitesby Dermat and Subject post 1 week of patch removal and tracking the positive cases**)**

**Population 24 healthy subjects(12 males + 12 females) The subjects are selected on the** **basis of skin types:**

3 males + 3 females for dry skin

3 males + 3 females for oily skin

3 males + 3 females for combination skin

3 males + 3 females for normal skin

**Products :** Shampoo (17821), Face Wash (FAPM 61/07),Face Wash (FAPM 61/16),Face Wash (TSP 56-194B), Shower Gel( TSP 56-197A) ,Soap(FG-5064)

**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**

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-18
• Study Completion: 2013-02-28
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

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

Inclusion Criteria

Skin is healthy on the studied anatomic unit (free of eczema,wounds, inflammatory scar….) Subjects representing varied skin types (ideally equal representation of all 4 skin types – Oily, Normal, Dry and combination) Subjects willing to come for regular follow up and ready to follow instructions during the study period.

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, oriasis, 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 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
investigational products by primary irritation	T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
skin types	T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal
patch test on healthy human volunteers of varied	T0 (before patch application, T1(0 hours after | patch removal), T2(24 hours of patch removal, T8 (T+1 week after 0 hours of patch removal

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 Mary Francis

Principal investigator

022-43349191

mary@mascotspincontrol.in