Safety assessment of products on skin.

Completed

• Conditions: Varied Skin Types

• Registration Number: CTRI/2018/07/014999
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human subjects of varied skin types. Test products will be tested against control involving 24 subjects. Total duration is 10 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-28
• Study Completion: 2018-08-14
• 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& 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