NCT05079607

Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

A Modified Draize Repeat Insult Patch Test in a Shared Panel of 50/100 Healthy Volunteers, to Investigate the Irritation and Sensitization Potential of Test Articles Following Repeated Cutaneous Patch Applications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Amazentis SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method

Conditions

• Irritation/Irritant
• Sensitisation

Interventions

Type	Name	Description
OTHER	Mitopure Topical Formula 1	topical skin cream containing the low dose mitophagy activator Mitopure
OTHER	Mitopure Topical Formula 2	topical skin cream containing the high dose mitophagy activator Mitopure

Timeline

• Start date: 2021-10-04
• Primary completion: 2021-11-15
• Completion: 2021-11-15
• First posted: 2021-10-15
• Last updated: 2021-11-23

Locations

1 site across 1 country: United Kingdom