To know the safety of Investigational products on healthy human volunteers

Completed

• Conditions: Varied Skin Types

• Registration Number: CTRI/2019/07/020075
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Single Application Semiocclusive, Closed Patch test is conducted to measure the irritation potentialof cosmetic products on the skin

Objective: To evaluatethe irritation potential on healthy human subjects of Skin CareFormulations.

Duration of study: 8 days study

Kinetics: T0 (Evaluation oftest sites by Dermatologist, Patch application)

T1(Patchremoval, Evaluation of test sites by Dermatologist

T2(Evaluationof test sites by Dermatologist and Subject post 24 hrs of patchremoval),

T8 (Evaluation of test sites byDermat and Subject post 1 week of patch removal and tracking the positive cases)

Population 24 healthy subjects(12 males + 12 females)

The test area is checked forerythema and oedema caused due to the products and compared with positivecontrol.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Study Completion: 2019-07-18
• Last Update Posted: 2022-08-01

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
Safety assessment of products	Baseline,0 hrs,24 hrs and 7 days

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 (Suburban), MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳(Suburban), MAHARASHTRA, India

Dr Siddheshwar Mathpati

Principal investigator

022-43349191

siddheshwar@mascotspincontrol.in