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

26 mai 2026 mis à jour par: Vitro Biopharma Inc.

Proof of Concept Split-Face Single-Blind Study to Assess the Cosmetic Appearance of Skin on Subjects Using the Vitro Biopharma Secretome/Exosome Serum

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

7

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Chestnut Hill, Massachusetts, États-Unis, 02467
        • SkinCare Physicians

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention v Control
Autre: Secretome/Exosome Serum
The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
Délai: 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.
Procedure Day through Day 90 follow-up (assessments at 1 hour, Day 1, 7, 21, 45, 46, 52, 66, and 90)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
Délai: 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.
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
Délai: 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.
Day 45 and Day 90 follow-up (live assessment); post-Day 90 image-based assessment
Change from Baseline in Transepidermal Water Loss (TEWL)
Délai: 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.
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
Délai: 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.
Follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change from Baseline in Skin Radiance on the Modified Griffiths 10-Point Scale by Blinded Evaluator
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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.
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
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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
Délai: Day 45 and Day 90 follow-up (live); post-Day 90 image-based assessment
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
Délai: Pre-Treatment (baseline) and follow-up Days 1, 7, 21, 45, 46, 52, 66, and 90
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)
Délai: Baseline (pre-procedure) and Day 90 follow-up
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
Délai: 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)
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
Délai: 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)
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
Délai: 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)
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
Délai: 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)
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vitro Biopharma Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 avril 2024

Achèvement primaire (Réel)

30 janvier 2025

Achèvement de l'étude (Réel)

30 janvier 2025

Dates d'inscription aux études

Première soumission

13 mai 2026

Première soumission répondant aux critères de contrôle qualité

26 mai 2026

Première publication (Réel)

2 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Vitro Biopharma 001 (VB001)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Only the individual participant data (IPD) used in the results publication will be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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