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

Completed · Not applicable

Conditions studied: Cosmetic Effect

In brief

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.

Key facts

Study ID

NCT07620158

Run by

Vitro Biopharma Inc.

People needed

7

Starts

2024-04-17

Expected to finish

2025-01-30

Last updated by the study team

2026-06-02

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 or other physical features in the area of treatment that may confound the outcome in the investigators opinion
• Active implanted device such as pacemaker, defibrillator, drug delivery system
• Pregnant or intending to become pregnant
• Lactating or has been lactating in the last 6 months
• History of coagulopathy, or taking anticoagulants
• Taking daily oral aspirin
• Immunocompromised or immunosuppressed
• Active, chronic or recurrent infection
• Hypersensitivity to analgesic agents
• History of keloid scar formation
• Chronic disease such as diabetes, hepatitis, etc.
• Oral corticosteroids or topical steroids in the treatment area
• Prescription or over the counter (OTC) medication or cosmetics applied to treatment area containing: retinoids, glycol acid, salicylic acid or any other remedies that might affect the healing process.
• Co-morbid condition that could limit ability to participate in the study or comply with follow-up requirements
• Untreated drug and/or alcohol abuse

Where it is running

• Skincare Physicians — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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