Safety assessment of products on skin

Not yet recruiting

• Conditions: Normal skin type

• Registration Number: CTRI/2021/05/033366
• Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary

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

Objective: To evaluate the irritation potential on healthy human subjects of Skin and Hair Care Formulations.

Duration of study: 8 days study

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

T1(Patch removal, Evaluation of test sites by Dermatologist

T2(Evaluation of test sites by Dermatologist and Subject post 24 hrs of patch removal),

T8 (Evaluation of test sites by Dermat 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 for erythema and oedema caused due to the products and compared with positive control.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

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, 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	0 hrs, 24 hrs & 7 days

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