Safety assessment of skin care and hair care formulations

Not yet recruiting

Conditions: Normal Skin Volunteers

Registration Number: CTRI/2021/08/035771

Lead Sponsor: Kama Ayurveda Pvt Ltd

Brief Summary: 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

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. Healthy Human Subjects 2) is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ€¦.).
1. 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 product	Baseline,0 hrs,24 hrs and 7 days

Secondary Outcome Measures

Name	Time	Method

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