Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

26 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

7

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Chestnut Hill, Massachusetts, Estados Unidos, 02467
        • SkinCare Physicians

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention v Control
Outro: Secretome/Exosome Serum
The Vitro Biopharma Exosome Serum contains extracellular vesicles derived from umbilical cord MSCs

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants with Procedure-Related Adverse Events by Symptom and Severity
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference Between Intervention and Control Sides in Incidence of Anticipated Microneedling-Related Adverse Events
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Skin Radiance on the Modified Griffiths 10-Point Scale by Blinded Evaluator
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Vitro Biopharma Inc.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de abril de 2024

Conclusão Primária (Real)

30 de janeiro de 2025

Conclusão do estudo (Real)

30 de janeiro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de maio de 2026

Primeira postagem (Real)

2 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Vitro Biopharma 001 (VB001)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever