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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention v Control | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secretome/Exosome Serum | Other | The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Procedure-Related Adverse Events by Symptom and Severity | 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. | Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Skin Radiance on the Modified Griffiths 10-Point Scale by Blinded Evaluator | Skin radiance improvement on each treatment area will be rated by a blinded evaluator using the Modified Griffiths 10-point scale (0 = No Improvement; I to III = Mild; IV to VI = Moderate; VII to IX = Best Improvement), per Protocol Appendix G. Mean score per side and between-side difference will be reported. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skincare Physicians | Chestnut Hill | Massachusetts | 02467 | United States |
Only the individual participant data (IPD) used in the results publication will be shared.
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| ID | Term |
|---|---|
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D055442 | Metabolome |
| D008660 | Metabolism |
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| 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) |
| Change from Baseline in Global Aesthetic Improvement Scale (GAIS) Score by Blinded Evaluator | 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. | Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment |
| Change from Baseline in Transepidermal Water Loss (TEWL) | 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. | Time Frame: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90 |
| Change from Baseline in Subject-Reported Clinical Global Impression-Improvement (CGI-I) Score | 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. | Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90 |
| Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Skin Tone Evenness on the Modified Griffiths 10-Point Scale by Blinded Evaluator | Skin tone evenness on each treatment area will be rated by a blinded evaluator using the Modified Griffiths 10-point scale (None (0); Mild (I to III); Moderate (IV to VI); Severe (VII to IX) unevenness of red/brown patches or spots), per Protocol Appendix G. Mean score per side and between-side difference will be reported. | Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Surface Roughness on the Allergan Skin Roughness Scale by Blinded Evaluator | Visual surface roughness on each treatment area will be rated by a blinded evaluator using the Allergan Skin Roughness Scale (0 = None, 1 = Minimal, 2 = Moderate, 3 = Severe, 4 = Extreme), per Protocol Appendix G. Mean score per side and between-side difference will be reported. | Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Cheek and Midface Wrinkle Severity on the Allergan Fine Lines Scale by Blinded Evaluator | Cheek and midface fine line severity on each treatment area will be rated by a blinded evaluator using the Allergan Fine Lines Scale (0 = None, 1 = Minimal, 2 = Moderate, 3 = Severe, 4 = Diffuse), per Protocol Appendix G. Mean score per side and between-side difference will be reported. | Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Periorbital Wrinkle Severity at Rest on the Merz Scale by Blinded Evaluator | Periorbital wrinkle severity at rest on each treatment area will be rated by a blinded evaluator using the Merz Scale (0 = No Wrinkles, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe), per Protocol Appendix G. Mean score per side and between-side difference will be reported. | Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Dynamic Periorbital Wrinkle Severity (Smiling) on the Merz Scale by Blinded Evaluator | Periorbital wrinkle severity while smiling on each treatment area will be rated by a blinded evaluator using the Merz Scale (0 = No Wrinkles, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very Severe), per Protocol Appendix G. Mean score per side and between-side difference will be reported. | Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment |
| Change from Baseline in Skin Viscoelasticity by Cutometer Measurement | Mechanical/viscoelastic properties of the skin will be measured at each treatment area using a Cutometer, reported as the R2 (gross elasticity) parameter. Mean change from baseline at each post-procedure time point and the difference between intervention and control sides will be reported. | Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90 |
| Change from Baseline in Subject Satisfaction with Facial Skin Attributes (5-Point Likert Scale) | Subjects will rate satisfaction with five facial skin attributes (presence of wrinkles under the eyes, presence of wrinkles on the cheeks, smoothness, radiance/brightness, and tone evenness) on a 5-point Likert scale (1 = Very Satisfied, 2 = Somewhat Satisfied, 3 = Neither Satisfied nor Dissatisfied, 4 = Somewhat Dissatisfied, 5 = Very Dissatisfied) at baseline (Protocol Appendix E) and at final follow-up (Protocol Appendix H) for each treatment side. Mean change per attribute per side and between-side difference will be reported. | Baseline (pre-procedure) and Day 90 follow-up |
| Number of microRNAs (miRNAs) Demonstrating Consistent Directional Change in Expression on the Intervention Side Compared to the Control Side by NanoString miRNA Profiling | Punch biopsies of periauricular skin obtained pre-procedure (baseline), post-control side procedure, and post-intervention side procedure will undergo RNA extraction and miRNA expression profiling by NanoString miRNA technology at a blinded contract laboratory. Raw Reporter Code Count (RCC) files will be background-normalized using negative-control probe thresholds, and low-expressing miRNAs will be removed. Percent-change from baseline will be calculated separately for the control and intervention sides. A tiered filtering algorithm will identify miRNAs meeting cross-subject directional consistency and a magnitude threshold on the net-effect calculation. The total number of miRNAs meeting these pre-specified criteria will be the reported endpoint. Descriptive breakdowns of the identified miRNAs will be reported in tables. | Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90) |
| Histologic Assessment of Elastic Fiber Architecture in Skin Biopsy (Van Gieson Stain) by Blinded Dermatopathologist | Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure. Sections will be stained with Van Gieson and evaluated by a board-certified dermatopathologist blinded to treatment assignment. Elastic fiber architecture in the papillary dermis on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased. The number of subjects in each directional category will be reported. | Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90) |
| Histologic Assessment of Collagen Fiber Density and Organization in Skin Biopsy (Masson's Trichrome Stain) by Blinded Dermatopathologist | Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure. Sections will be stained with Masson's Trichrome and evaluated by a board-certified dermatopathologist blinded to treatment assignment. Collagen fiber density and organization on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased. The number of subjects in each directional category will be reported. | Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90) |
| Histologic Assessment of Vascular Density in Skin Biopsy (H&E Stain) by Blinded Dermatopathologist | Punch biopsies of periauricular skin will be obtained pre-procedure (baseline), 30 to 45 days post-control side procedure, and 30 to 45 days post-intervention side procedure. Sections will be stained with hematoxylin and eosin (H&E) and evaluated by a board-certified dermatopathologist blinded to treatment assignment. Vascular density on the intervention side will be categorized relative to the matched control side as increased, unchanged, or decreased. The number of subjects in each directional category will be reported. | Pre-procedure (baseline); 30 to 45 days post-control side procedure (study Days 30 to 45); 30 to 45 days post-intervention side procedure (study Days 75 to 90) |