Healthy Adult
Conditions
Keywords
Safety In Use
Brief summary
The objective of this study is to investigate the safety of 1 topically applied test article containing Mitopure in a panel of healthy volunteers.
Interventions
OTHERMitopure Topical Formula
Topical skin serum containing Mitopure
Sponsors
Amazentis SA
Princeton Consumer Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female participants aged 18+. * Participant has signed a written Informed Consent. * Participant must agree to refrain from taking any new medications or herbal supplements during the study, unless permitted by the investigator. * Participant does not have grade of 3 or higher of any skin attribute per the grading scale. * Participant is willing to ONLY use the test article on themselves during the study as instructed and not use other facial serum products. * Participant is willing to attend all study visits and to follow the study instructions and prohibitions. * Participant must agree to refrain from using any new facial serum products, cleansers, laundry detergents, fragrances while participating in this study.
Exclusion criteria
* Participant is pregnant, nursing, or planning to become pregnant (by verbal response only). * Participant has a current skin disease of any type (e.g., eczema, psoriasis, rosacea, atopic dermatitis, vitiligo). * Participant has a known allergy to face serum products, or the ingredients included in the test article. * Participant has a history of malignant disease. * Participant has cuts, scratches, abrasions, rashes, scarring, birthmarks, or tattoos on their face that may interfere with assessments. * Participant has a significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease. * Participant has a known sensitivity to the test article, similar materials, or their constituents. * Treatment or medication containing sympathomimetics, antihistamines or corticosteroids in the seven days prior to study start. * Medical condition that may affect study data or participant safety which in the opinion of the Investigator would compromise the safety of the participant or study results. * History of poor cooperation, non-compliance, or unreliability. * Investigator deems the participant an unsuitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation | 2 weeks | Visual evaluation by an expert clinical grader at Baseline and Week 2 for skin condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product traits | 2 weeks | Subjective evaluation of product traits assessed via questionnaire after 2 weeks. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick: 2 = Fully disagree; 1 = Rather disagree; 1. = Rather agree; 2. = Fully agree |
Countries
United Kingdom
Outcome results
None listed