Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device (NCT07372001) | Clinical Trial Compass
CompletedPhase 4
Effects on Facial Skin Aging After Topical Application of Exosomes With a Microneedling Device
Mexico30 participantsStarted 2024-07-01
Plain-language summary
In this study, we evaluated the extent of reversal of facial dermal aging signs using topical lyophilized exosomes with a microneedling device
Who can participate
Age range
50 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:
* Men and women over the age of 50 with facial rhytides and a minimum score of 12 on the SASSQ scale
Exclusion Criteria:
* pregnancy or breastfeeding, active acne or rosacea, local infections, lesions suspicious for malignancy, and allergy to exosomes. The elimination criteria involved loss of follow-up of the research subject and the occurrence of an allergic reaction or intolerable adverse effects.
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.
1This trial tested a combination of exosomes and microneedling for facial skin aging — since it's already completed, would my doctor be able to find out what the results showed before I consider any similar treatment?
2Because this was a Phase 4 trial, does that mean the microneedling device used was already approved, and how does that affect what we know about its safety compared to the exosome component?
3The trial measured both objective dermal changes and patients' own subjective evaluations — is there a meaningful difference between those two types of results, and which one should matter more to me when deciding if this approach is right for my situation?
4Are exosomes combined with microneedling something my doctor currently offers or considers evidence-based, or would a more established skin treatment be a better starting point for me?
5What kinds of side effects or skin reactions are generally associated with microneedling combined with topical agents like exosomes, and are there any factors in my health history that would make this approach riskier for me?
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
Facial dermal changes
Timeframe: From enrollment to the end of treatment at 8 weeks
2
Subjective evaluation of facial dermal changes
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT07372001
SponsorInstituto de Oftalmología Fundación Conde de Valenciana