Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
NCT05079607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2021-11-23
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
- 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
Sponsors & Collaborators
-
Princeton Research Corporation
collaborator UNKNOWN -
Amazentis SA
lead INDUSTRY
Principal Investigators
-
Anurag Singh, MD, PhD · Amazentis SA
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-04
- Primary Completion
- 2021-11-15
- Completion
- 2021-11-15
Countries
- United Kingdom
Study Locations
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