Human Skin Safety Testing of Mitopure Topical Products Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
NCT06884215 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112
Last updated 2025-05-21
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 3
Topical skin cream containing Mitopure
- OTHER
-
Mitopure Topical Formula 4
Topical skin cream containing 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
- 2025-03-17
- Primary Completion
- 2025-04-28
- Completion
- 2025-04-28
Countries
- United Kingdom
Study Locations
More Related Trials
-
A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests
NCT03406117 ·Status: COMPLETED ·Phase: PHASE4
-
To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products
NCT04007159 ·Status: COMPLETED ·Phase: NA
-
50 Human Subject Repeat Insult Patch Test
NCT04498676 ·Status: COMPLETED ·Phase: NA
-
21 Day Cumulative Skin Irritation of RUT058-60
NCT02198963 ·Status: COMPLETED ·Phase: PHASE1
-
Repeat Insult Patch Test APPENDIX I to HRL Standard Protocol #100
NCT03450070 ·Status: COMPLETED ·Phase: NA
-
Prospective Single Center Randomized Double Blind Controlled Tolerability Trial of Six Hair Cleansing Conditioners
NCT03483025 ·Status: COMPLETED ·Phase: NA
-
To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects.
NCT07065149 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Study to Evaluate the Irritation Potential of ATx201 in Healthy Volunteers
NCT03301870 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
NCT00883311 ·Status: COMPLETED ·Phase: PHASE2
-
Sensitization Study of ATx201 in Healthy Volunteers
NCT03375957 ·Status: COMPLETED ·Phase: PHASE1
-
Cumulative Irritation Test of PAC-14028 in Healthy Volunteers
NCT01638117 ·Status: COMPLETED ·Phase: PHASE1
-
Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch
NCT04624867 ·Status: UNKNOWN ·Phase: PHASE1
-
Cumulative Irritation Potential of 828 Ointment
NCT00767455 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
NCT01816542 ·Status: UNKNOWN ·Phase: NA
-
To Assess Skin Safety of Test Product(s) by Patch Test on Adult Healthy Human Subjects
NCT07109453 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Epicutaneous Testing of Cosmetics for Skin Compatibility
NCT03024671 ·Status: RECRUITING ·Phase: NA
-
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment
NCT00644917 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
NCT00640614 ·Status: COMPLETED ·Phase: PHASE3
-
Human Repeated Insult Patch Test
NCT03474874 ·Status: COMPLETED ·Phase: NA
-
Inter-arm and Inter-period Reproducability of the Dermal Blood Flow Response After a Histamine Skin Prick.
NCT04396977 ·Status: COMPLETED ·Phase: NA
-
18348-Human Phototoxicity Test
NCT02823483 ·Status: COMPLETED ·Phase: NA
-
Clinical Evaluation of the Photoallergy Potential of Xenaderm Ointment
NCT00645164 ·Status: COMPLETED ·Phase: PHASE1
-
Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema
NCT03619161 ·Status: COMPLETED ·Phase: NA
-
A 47 Hour Occlusive Cutaneous Skin Patch Test on Adult Subjects With Dry/Atopic Skin
NCT02620293 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Skin Irritation Potential of PBI-100 Topical Cream in Healthy Participants
NCT04882631 ·Status: COMPLETED ·Phase: PHASE1