Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (H… (NCT05079607) | Clinical Trial Compass
CompletedNot Applicable
Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers
United Kingdom112 participantsStarted 2021-10-04
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 exa…
What they're measuring
1
Skin safety as assessed by the number of adverse events of skin irritation and sensitization during human repeat insult patch testing (HRIPT)