Safety assessment of products

Not yet recruiting

• Conditions: Normal Skin Type

• Registration Number: CTRI/2021/02/031594
• Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary

Objective: The objective of this study is to evaluate the sensitization potential of Skin Care formulations on healthy human subjects

Population of 120 healthy subjects (60 males + 60 females)

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

T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application

T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal

T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading

**14 DAYS RESTING PHASE**

T21 – Patch Application

T22 – Patch Removal

T23 - 24 hour post patch removal grading

T24 - 48 hour post patch removal grading

T25 - 72 hour post patch removal grading

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-02-25
• Study Start: 2021-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 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, Poriasis, 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	T0, T2, T4, T7, T9, T11, T14, T16, T18 – Patch Application | T1, T3, T5, T8, T10, T12, T15, T17, T19 – Patch Removal | T2, T4, T6, T9, T11, T13, T16, T18, T20 - 24-hour post patch removal grading | 14 DAYS RESTING PHASE | T21 – Patch Application | T22 – Patch Removal | T23 - 24 hour post patch removal grading | T24 - 48 hour post patch removal grading | T25 - 72 hour post patch removal grading

Trial Locations

Locations (1)

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

Mascot Spincontrol India Pvt. Ltd.

🇮🇳(Suburban), MAHARASHTRA, India

Dr Raji Patil

Principal investigator

022-43349191

raji@mascotspincontrol.in