Cosmetic Effect
Conditions
Brief 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.
Interventions
OTHERSecretome/Exosome Serum
The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs
Sponsors
Vitro Biopharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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 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 * Unable or unwilling to comply with the study requirements * Enrolled in another clinical study or taking any unknown or not Food and Drug Administration (FDA) approved medications * Any other condition or presentation that in the opinion of the Investigator might exclude the subject * Intends to begin any new skin medications in the treatment areas * Intends to change their daily skincare routine before or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Procedure-Related Adverse Events by Symptom and Severity | Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90) | Adverse events related to the procedure (microneedling with or without Vitro Biopharma Exosome Serum) will be assessed at each in-person follow-up visit using the Clinical Safety Assessment (Protocol Appendix D). Physician-assessed events include erythema, edema, and scabbing/peeling/dry skin. Subject-reported events include pain, pruritis, paresthesia, and discomfort. Each event will be recorded as present or absent with severity graded as Mild, Moderate, or Severe. Number of participants with each event by severity grade will be reported for each treatment side. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events | Post-procedure Days 1, 7, 21, and 45 on each treatment side (study Days 1, 7, 21, 45 for control; study Days 46, 52, 66, 90 for intervention) | For each anticipated microneedling-related event (erythema, edema, scabbing/peeling/dry skin, pain, pruritis, paresthesia, discomfort) defined in Protocol Appendix D, the number of participants reporting the event on the intervention (Exosome Serum) side will be compared to the number reporting the event on the control (no Exosome Serum) side at matched post-procedure time points. |
| Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Score by Blinded Evaluator | Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment | Aesthetic improvement of each treatment area relative to baseline images will be rated by a blinded evaluator using the 5-point GAIS (1 = Exceptional Improvement, 2 = Very Improved, 3 = Improved, 4 = Unaltered, 5 = Worsened). Mean GAIS score will be reported per treatment side at each assessment, and the difference between intervention and control sides will be reported. |
| Change from Baseline in Transepidermal Water Loss (TEWL) | Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90 | TEWL will be measured at each treatment area using a topical probe with temperature and relative humidity sensors, reported in g/m²/h. Mean change from baseline at each post-procedure time point and the difference between intervention and control sides will be reported. |
| Change from Baseline in Subject-Reported Clinical Global Impression-Improvement (CGI-I) Score | Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90 | At each follow-up visit, subjects will rate overall appearance of each treatment area compared to before the procedure using the CGI-I (1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse), per Protocol Appendix F. Mean score per side at each time point and the between-side difference will be reported. |
Countries
United States
Outcome results
None listed