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

Sensitisation Clinical Trial

— GLOW-Safety  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05079607
• Other study ID #: ASARIP1M
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: Amazentis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Irritation/Irritant
• Sensitisation

Intervention

Other:
• Mitopure Topical Formula 1
topical skin cream containing the low dose mitophagy activator Mitopure
• Mitopure Topical Formula 2
topical skin cream containing the high dose mitophagy activator Mitopure

Locations

Country	Name	City	State
United Kingdom	PCR Corp, 667A Stockport Road	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Amazentis SA	Princeton Research Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)		6 weeks