NCT07065149

To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects.

Dermatological Safety Assessment of Test Products Using Primary Irritation Patch Test (PIPT) in Healthy Adult Human Subjects

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To Check Dermatological Safety of Test Products by 24 Hours Patch Testing

Detailed description

This is single center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion \|Semi occlusion \|Open patch for at least 24 hours (+ 2 hours). Study can be conducted in multiple groups. Safety will be assessed throughout the study by monitoring of adverse events. Subject's back i.e. between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.

Conditions

• Normal Skin

Interventions

Type	Name	Description
OTHER	1)0.1% Pinorox® Cream 2)1% Pinorox® Cream 3)Base cream 4)Positive control 5)Negative control	0.04 gm of each Test Products along with positive control (1% SLS) and negative controls will be applied on the back of subjects i.e. between the scapula and waist through finn chamber patch.

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-07-15
• Last updated: 2025-08-08