Randomised Controlled Trial of an Antioxidant and Sunscreen Combination Cream for Reducing DNA Da… (NCT07301515) | Clinical Trial Compass
CompletedNot Applicable
Randomised Controlled Trial of an Antioxidant and Sunscreen Combination Cream for Reducing DNA Damage in Human Skin
United Kingdom52 participantsStarted 2025-03-01
Plain-language summary
This randomized, double-blind, vehicle-controlled clinical trial investigates whether daily use of an encapsulated SPF 50 formulation containing a multi-antioxidant complex provides greater mitochondrial DNA (mtDNA) protection in human facial skin compared with a vehicle-only cream.
Fifty-two healthy adults will be enrolled during the UK spring and randomized 1:1 to receive either the antioxidant-enriched SPF 50 or a matched vehicle (no SPF, no antioxidants). Participants will apply their assigned product once daily to the full face for 12 weeks under ambient ultraviolet (UV) and oxidative exposure.
Non-invasive cheek swabs collected at baseline and week 12 will be analyzed by blinded quantitative polymerase chain reaction (qPCR) to assess mtDNA integrity (ΔCt = Ct\_long - Ct\_short).
The primary objective is to determine whether the antioxidant-enriched SPF 50 reduces mtDNA damage compared with vehicle. Secondary objectives include comparing the proportion of "responders" showing reduced mtDNA damage (ΔCt \< 0) and evaluating within-participant change among habitual daily sunscreen users.
The trial aims to clarify whether adding antioxidants to high-SPF formulations can strengthen daily photoprotection by mitigating residual oxidative stress not fully blocked by UV filters alone.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18-80 years
* Healthy facial skin with no active dermatologic disease
* Willing to apply the assigned product daily for 12 weeks
* Willing to avoid additional facial skincare products during the study period
* Able to attend baseline and week-12 visits for cheek-swab collection
* Willing to maintain stable medication and supplement use throughout the study
* Provided written informed consent
Exclusion Criteria:
* Active facial dermatologic disease or visible facial skin lesions
* Laser, peel, or energy-based facial treatment within the past 3 months
* Use of topical/systemic retinoids, antioxidants, or anti-inflammatory agents within 4 weeks of baseline
* Pregnancy or breastfeeding
* Recent acute illness or infection
* Planned travel to high-UV or sunny destinations during the study period
* Current smoker or regular e-cigarette user
* Participation in another clinical trial within the previous 30 days
* Known allergy or sensitivity to study-product ingredients
* Unstable medical conditions or medications known to affect mitochondrial function (e.g., recent changes in antibiotics, statins, or thyroid medication)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Change in Mitochondrial DNA Damage (ΔCt) Between Active and Vehicle Creams Measured by Long-Amplicon Quantitative PCR