CompletedNot Applicable

Proof of Concept Study to Isolate Cosmetic Improvement of Skin Using the Vitro Biopharma Secretome/Exosome Serum

United States7 participantsStarted 2024-04-17

Plain-language summary

The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure.

Who can participate

Age range

30 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: * Male or female subjects over 30 years of age * Non-smoker * Fitzpatrick scale II-IV * Mild to moderate skin wrinkles or fine lines around the eyes (periorbital) and/or radial cheek * Subject agrees to maintain their weight (i.e. within 5%) by not making any major changes in diet of lifestyle during study * Able to provide written informed consent, understand and willing to comply with study related procedures and follow-up * Willing to undergo facial microneedling treatment * Willing to sign photo release (For study purposes and potential publication) Exclusion Criteria: * Prior trauma, surgical procedure or invasive cosmetic procedure in the area of intended treatment * Fat reduction/removal procedure in or around the area of intended treatment up to 1 year prior to enrollment * Cosmetic injections into the area of intended treatment including botulinum toxin injections up to 6 months prior or filler injections up to 1 year prior to enrollment * Ablative or non-ablative dermal resurfacing procedures within 6 months of screening * Skin tightening procedures on the face within the past 3 months * Currently using prescription facial wrinkle therapies * History of bleeding disorder, or is taking any medication that may increase risk of bruising * Dermatological conditions in the location of the treatment sites that may interfere with treatment * Subject has an active infection * Subject has a known metal allergy * Pre-existing scars, tattoos, birthmarks …

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

Number of Participants with Procedure-Related Adverse Events by Symptom and Severity

Timeframe: Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)

Trial details

NCT IDNCT07620158

SponsorVitro Biopharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Cosmetic Effect trials

Who can participate

Age range

30 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.