Clinical trial NCT05079607: Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritation/Irritant
Sensitisation
Keywords: HRIPT
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: Princeton Research Corporation
First posted: 2021-10-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: Inclusion Criteria:

* Healthy males or females,18 years of age or older.
* Completed written informed consent.
* Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

Exclusion Criteria:

* Pregnancy or lactation.
* A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis) or has tattoos or excessive hair at the patch sites that would interfere with patching/skin evaluations.
* Heavy alcohol consumption (i.e. more than 21 units per week or 8 units a day for men, more than 14 units per week or 4 units a day for women).
* Current use or history of repeated use of street drugs.
* A febrile illness lasting more than 24 hours in the six days prior to first patch application.
* Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
* Currently taking asthma medication or antihistamines for hay fever.
* A history of multiple drug hypersensitivity.
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study (e.g. Anti-allergy, glucocorticoid, aspirin, non- steroidal anti-inflammatory, asthma or hay fever medication).
* Known sensitivity to the test articles or their constituents including patch materials (for example tape/plaster adhesive).
* Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
* Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
* Sensitisation or questionable sensitisation in a RIPT.
* Recent immunisation (less than 10 days prior to test patch application).
* A medical history indicating atopy.

Primary outcomes:
measure: Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: PCR Corp, 667A Stockport Road
Study officials:
affiliation: Amazentis SA
name: Anurag Singh, MD, PhD
role: STUDY_DIRECTOR
References: