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Uso pós-operatório de FS2 para mitigar cicatrizes em pacientes queimados

29 de setembro de 2026 atualizado por: Birch BioMed Inc

Administração tópica pós-operatória de fibrose inibindo o composto FS2 em um estudo duplo-cego, randomizado e controlado por veículos, avaliando a segurança e a mitigação de cicatrizes cutâneas em locais de enxerto e doadores em pacientes queimados em pacientes

The goal of this study is to see how an ingredient called kynurenic acid (which we named "FS2") affects scar formation in people with burn injuries that need skin graft surgery. A cream with FS2 will be used on both the area where the skin graft was placed and the area where the skin was taken (donor site). The cream will be applied after the skin has healed. This study will help us understand if FS2 is safe and effective for mitigating skin scar formation in burn patients.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

For the first 90 days of the study, neither the patient nor the investigator will know which cream is being used: either the control cream (IP1) or the treatment cream (IP2), which contains 0.5% FS2. The assigned study product will be applied to the donor site and the skin graft site. After the first 90 days, all patients will use the FS2 cream for another 90 days in an open-label period where everyone knows they are receiving FS2.

The graft and donor sites will be photographed and assessed (POSAS and VSS), scored and recorded at the initial visit and again at every assessment visit thereafter.

An interim analysis will take place when about half of the participants (36 people) have finished their Day 90 visit. Based on the results, the study may continue as planned with the two-treatment, blinded design, or it may switch to an open-label format where all patients (those already in the study or newly enrolled) will use the FS2 cream.

Oversight - Human Subjects Protection Review section continued:

Site #02 (Edmonton) Approval Number: Pro00151882 Board Name: HREB - Biomedical Panel Board Affiliation: HREB - University of Alberta Board Contact Information: 780-492-8320 (Phone), vnadeau@ualberta.ca (Email)

Tipo de estudo

Intervencional

Inscrição (Estimado)

70

Estágio

  • Fase 2
  • Fase 3

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.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2B7
        • Recrutamento
        • University of Alberta, Division of Plastic Surgery
        • Contato:
        • Investigador principal:
          • Alex Morzycki, MD
    • Ontario
      • Hamilton, Ontario, Canadá, L8L 2X2
        • Recrutamento
        • Centre for Burn Research - Hamilton Health Sciences
        • Contato:
        • Contato:
        • Investigador principal:
          • Marc Jeschke, PHD
        • Subinvestigador:
          • Stephanie Chadwick, MD

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

12 anos a 65 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Medically able and willing to consent/assent to study requirements
  2. Male and female burn patients
  3. 12 to 65 years of age (inclusive)
  4. Able to understand the study requirements and consent without a translator. Where applicable, participant's legally authorized representative (LAR) is willing and able to agree to the requirements and restrictions of the study, be willing to give voluntary informed consent (or assent, if capable), be able to understand and read the questionnaires, carry out all study-related procedures, and communicate effectively with the study staff.
  5. Have a BMI between 15 and 35 kg/m2 (inclusive)
  6. Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
  7. Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
  8. Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
  9. If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
  10. Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers

Exclusion Criteria:

  1. Medically unable to consent to study requirements
  2. Treatment site(s) (skin graft site) located on the face and genitalia
  3. Treatment site(s) (skin graft site and skin donor site) that has not reached complete re-epithelization at baseline, based on the investigator's assessment
  4. Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
  5. Pregnant, or attempting to become pregnant
  6. Subjects who had taken part in an interventional clinical trial within 3 months prior to admission to this trial or who are currently participating in a clinical trial, whether an investigational drug was used or not
  7. Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
  8. Subjects who smoke more than 20 cigarettes a day
  9. Subjects who have a history of heavy drinking in the past month, defined as more than 14 drinks per week for men or more than 7 drinks per week for women
  10. Subjects who have a history of substance abuse within the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention)
  11. Subjects with severe inhalation injury requiring FiO2 >50%, renal failure requiring dialysis or hemodynamic instability requiring vasopressor therapy at the time of initiation of study treatment
  12. Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment sites
  13. Subjects with a history of abnormal keloid scarring
  14. Subjects with additional concurrent illnesses or conditions that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, uncontrolled HIV infection, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing
  15. Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
  16. A history of radiotherapy to the study scar area
  17. Subjects who have known sensitivity to any components of the IPs
  18. Any other diagnosis, condition, physical or geographical limitation with the participant

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: Ciência básica
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Skin Grafted wound

The wound site (injury)
Medicamento: IP1 control cream (Vehicle base)

Without FS2

Medicamento: IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base
Experimental: Donor Skin Graft Harvest wound

A Surgical wound
Medicamento: IP1 control cream (Vehicle base)

Without FS2

Medicamento: IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
Prazo: 90 days

To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by Vancouver Scar Scale (VSS) at the skin grafted wound (Study Arm 1)
90 days

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
Prazo: 90 days

To evaluate the effect of 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at the donor skin graft harvest site (Study Arm 2)
90 days
Scar condition of the skin graft wound on Day 28 and Day 60 as assessed by VSS
Prazo: Day 28 and Day 60

To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: skin grafted wound (Study Arm 1)
Day 28 and Day 60
Scar condition of the donor skin graft harvest site on Day 28 and Day 60 as assessed by VSS
Prazo: Day 28 and Day 60

To evaluate the effect of 28- and 60-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by VSS at: donor skin graft harvest site (Study Arm 2)
Day 28 and Day 60
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by the Observer component of Patient and Observer Scar Assessment Scale (POSAS) at skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Observer component of POSAS
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on clinician-assessed scar condition assessed by (POSAS) at: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar condition of the donor skin graft harvest site on Day 28, Day 60, and Day 90 as assessed by the Patient component of POSAS
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: skin grafted wound (Study Arm 1) -POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Observer component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - POSAS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Observer component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - POSAS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by VSS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: skin grafted wound (Study Arm 1) - VSS
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by VSS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on clinician-assessed scar condition at: donor skin graft harvest site (Study Arm 2) - VSS
Day 120 and Day 180
Scar condition of the skin grafted wound on Day 120 and Day 180 as assessed by the Patient component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar condition of the donor skin graft harvest site on Day 120 and Day 180 as assessed by the Patient component of POSAS
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on patient-reported scar condition at: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
Quality of life on Day 28, Day 60, and Day 90 as assessed by the Burn Specific Health Scale-Brief (BSHS-B)
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60- and 90-day FS2 cream use, compared to control, on burn injury-related quality of life
Day 28, Day 60 and Day 90
Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Prazo: Day 120 and Day 180

Quality of life on Day 120 and Day 180 as assessed by BSHS-B To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on burn injury-related quality of life in those randomized to control for the first 90 days of study
Day 120 and Day 180
Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on burn injury-related quality of life in those randomized to FS2 cream for the first 90 days of study Quality of life on Day 120 and Day 180 as assessed by BSHS-B
Day 120 and Day 180

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar height(cm) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: skin grafted wound (Study Arm 1)
Day 28, Day 60 and Day 90
Scar size(cm2) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar height(cm) at the donor skin graft harvest site on Day 28, Day 60 and Day 90 as assessed by photographs
Prazo: Day 28, Day 60 and Day 90

To evaluate the effect of 28-, 60-, and 90-day FS2 cream use, compared to control, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 28, Day 60 and Day 90
Scar size(cm2) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar height(cm) at the skin grafted wound on Day 120 and Day 180 as assessed by photographs
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: skin grafted wound (Study Arm 1)
Day 120 and Day 180
Scar size(cm2)at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
Prazo: Day 120 and Day 180

To evaluate the effect of 120- and 180-day FS2 cream use on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
Scar height(cm) at the donor skin graft harvest site on Day 120 and Day 180 as assessed by photographs
Prazo: Day 120 and Day 180

To evaluate the effect of 30- and 90-day FS2 cream use, starting 90 days after skin grafted wound's complete re-epithelization, on wound scarring from: donor skin graft harvest site (Study Arm 2)
Day 120 and Day 180
To evaluate the Safety of FS2 Cream - Adverse events
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Report of Adverse Events
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Whole Blood Hemoglobin (g/dl)
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Hematocrit (%)
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Blood Cell Count
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Red Cell distribution Width
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Volume
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean corpuscular Hemoglobin Concentration
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - White Blood Cell Count and Differential
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Platelet Count
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Mean Platelet Volume
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory Parameters - Hematology Parameters (Complete blood count)
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - AST
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety Laboratory parameters: Clinical Chemical Parameters
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - ALT
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters:
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - GGT
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Alkaline Phosphate
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Creatinine
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - BUN
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

To evaluate the safety of FS2 cream Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Total
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameters.
Day 0, Day 28, Day 60, Day 90 and Day 180
To evaluate the safety of FS2 cream - Bilirubin Direct
Prazo: Day 0, Day 28, Day 60, Day 90 and Day 180

Safety laboratory parameters: Clinical chemistry parameter.
Day 0, Day 28, Day 60, Day 90 and Day 180

Colaboradores e Investigadores

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

Patrocinador

Birch BioMed Inc

Colaboradores

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Investigadores

  • Diretor de estudo: Carlos Camozzi, MD, PHD, BirchBioMed 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 (Estimado)

1 de março de 2027

Conclusão Primária (Estimado)

1 de setembro de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de janeiro de 2025

Primeira postagem (Real)

4 de fevereiro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • B04-23-01-T0058

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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