Topical Mitopure product to reduce facial wrinkles
Anti-aging Efficacy Study on One Cosmetic Product vs Untreated
NA · Amazentis SA · NCT07517887
This study will test whether a face product containing Mitopure can improve skin health and reduce visible facial wrinkles in adults aged 45–65.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Amazentis SA (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Schenefeld) |
| Trial ID | NCT07517887 on ClinicalTrials.gov |
What this trial studies
Adults with visible facial wrinkles will be enrolled to apply a topical skincare product containing Mitopure and attend scheduled on-site visits for clinical evaluation and imaging. Enrollment targets both female participants and a small proportion of males with minimal facial hair, and requires healthy skin in the test areas and a proderm wrinkle score of 3–6. Participants will provide informed consent and some may consent to use of images for marketing in a subgroup. Common exclusions include pregnancy or lactation, active skin disease at the test area, known allergies to facial care ingredients, diabetes, infectious diseases, substance abuse, or recent participation in related cosmetic/pharmaceutical studies.
Who should consider this trial
Good fit: Ideal candidates are men (a small percentage with little facial hair) and women aged 45–65 with healthy facial skin and visible wrinkles (proderm grade 3–6) who can attend scheduled visits and provide informed consent.
Not a fit: People who are pregnant or breastfeeding, have active skin disease in the test area, known allergies to face-care ingredients, diabetes, immunocompromising infectious diseases, substance abuse issues, or recent enrollment in similar studies are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the product could visibly reduce wrinkle appearance and improve overall skin health for middle-aged adults.
How similar studies have performed: Topical antioxidant and mitochondrial-targeting approaches have shown modest skin-aging benefits in prior work, but topical use of Mitopure specifically is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA * Written Informed Consent to participate in the study * Written Informed Consent for the use of the images for marketing purposes applies to subgroup participants of study 26.0112. * Willingness to actively participate in the study and to come to the scheduled visits * Female * Male, approximately 10 to 15% with little facial hair * From 45 to 65 years of age * Healthy skin in the test areas * Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score) Exclusion criteria * Female participants: Pregnancy or lactation * Drug addicts, alcoholics * AIDS, HIV-positive or infectious hepatitis * Conditions which exclude a participation or might influence the test reaction/evaluation * Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area * Active skin disease at the test area * Documented allergies to face/eye care products or their ingredients * Diabetes mellitus * Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years * One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases * Epilepsy * Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation * Regular use of tanning beds within the last 6 weeks prior to the start of the study * Any topical medication at the test area within the last 3 days prior to the start of the study * Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study * Therapy with antibiotics within the last 2 weeks prior to the start of the study and throughout the entire course of the study that in the opinion of the investigator may affect the outcome of the study * Cosmetic surgery procedure in the test area (e.g. laser, facelift) within the last 2 years and throughout the entire course of the study * Cosmetic surgery treatments in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and throughout the entire course of the study * Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study and throughout the entire course of the study
Where this trial is running
Schenefeld
- SGS proderm GmbH — Schenefeld, Germany (RECRUITING)
Study contacts
- Study coordinator: Brad Currier, PhD
- Email: bcurrier@timeline.com
- Phone: +41215521274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aging, Wrinkle Appearance