Study to check safety of products on human volunteers

Not yet recruiting

• Conditions: Having Healthy skin on studied anatomic unit

• Registration Number: CTRI/2025/02/081224
• Lead Sponsor: Geenia International Pvt Ltd

Brief Summary

Objective: The objective of this study will be to evaluate the irritation potential on healthy human subjects of Skin 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: 26 healthy subjects (13 males + 13 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

• Last Update Posted: 2025-02-21
• Study Start: 2025-04-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit.

Exclusion Criteria

• 1)For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
• 2)Having refused to give his/her assent by not signing the consent form.
• 3)Taking part in another study liable to interfere with this study.
• 4. Being diabetic.
• 5. Being asthmatic.
• 6. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
• 7)Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
• 9. Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
• 10. Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dermatological safety / Irritation potential on skin	Baseline,0 hrs,24 hrs and 7 days

Trial Locations

Locations (1)

Mascot Spincontrol India Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

Mascot Spincontrol India Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Pooja Yadav

Principal investigator

02243349191

poojayadav@mascotspincontrol.in