NCT06631898

To Check Dermatological Safety of Test Products by 24 Hours Patch Test on Adult Healthy Human Subjects.

Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is single-center, evaluator blinded study in healthy human subjects. single 24-hour application of sponsors provided test product along with positive and negative control will be kept in contact with the skin if subject under icclllusion or semi occlusion or open patch for at least 24 hours (± 2 hours). safety will be assed through the study by monitoring of adverse event A sufficient number 26 subject will be enrolled to get 24 completed the study. There are total three visits in this study and are optional visit pre-screening visit : Lactic Acid Stinging test\& Modified Dr baumenn's skin type questionnaire. Visit 01: Screening, Enrollment, and Patch Application (Day 01) Visit 02: Patch Removal After 24 hours of Application \& 30 ± 5 min irritation scoring upon patch removal Visit 03: 24 (± 2 hour) irritation scoring (Day 03) visit 04: subject will be contacted telephonically on Day 08 for any signs of irritation at patch application site. Follow-up visit for reactions if any to confirm recovery (optional deemed necessary) Irritation scoring at 168 ± 2 hours post-patch removal (Day 09)

Conditions

• Normal Skin

Interventions

Type	Name	Description
OTHER	SaaTwae Bio-Natural Moisturizing Cream	A 0.04 gm of test products along with controls (negative and positive) will be applied on the back of subjects i.e. between the scapula and waist through Finn chamber patch.

Timeline

• Start date: 2024-10-09
• Primary completion: 2024-10-11
• Completion: 2024-10-17
• First posted: 2024-10-08
• Last updated: 2025-02-28

Locations

1 site across 1 country: India