NCT07109453

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
• Sensitive Skin

Interventions

Type	Name	Description
OTHER	18 Test Products along with positive and negative control	1\. Deep Hydration Gel 2. Anti-Wrinkle Gel 3. Anti-Aging Gel 4. Under Eye Cream 5. Brightening Cream 6. Moisturizing Cream 7. Anti-Acne Serum 8. Face Toner 9. Anti-Aging Toner 10. Clear Glow Toner 11. Super Anti-Aging Serum 12. Sun Screen SPF50 13. Anti-Pigmentation Serum 14. Super Cleansing Cream 15. Root Revive Hair Serum 16. Root Nourishment Hair Oil 17. Anti-Acne Face Wash 18. Ever Glow Face Wash 0.04 gm/ml 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: 2025-08-25
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-08-07
• Last updated: 2025-08-08