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Postoperatief gebruik van FS2 om littekens bij brandwonden te verminderen

29 september 2026 bijgewerkt door: Birch BioMed Inc

Post-operatieve actuele toediening van fibrose die samengestelde FS2 remt in een dubbelblinde, gerandomiseerde, voertuiggestuurde studie ter evaluatie van de veiligheid en mitigatie van cutane littekens bij huidtransplantaat en donorplaatsen bij brandwonden bij brandwonden

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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)

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Fase 2
  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Werving
        • Centre for Burn Research - Hamilton Health Sciences
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Marc Jeschke, PHD
        • Onderonderzoeker:
          • Stephanie Chadwick, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

12 jaar tot 65 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Skin Grafted wound

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

Without FS2

Geneesmiddel: IP2 - 0.5% w/w FS2

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

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

Without FS2

Geneesmiddel: IP2 - 0.5% w/w FS2

FS2 in pharmaceutical compounding base

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Birch BioMed Inc

Medewerkers

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Onderzoekers

  • Studie directeur: Carlos Camozzi, MD, PHD, BirchBioMed Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 maart 2027

Primaire voltooiing (Geschat)

1 september 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

22 januari 2025

Eerst ingediend dat voldeed aan de QC-criteria

31 januari 2025

Eerst geplaatst (Werkelijk)

4 februari 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 september 2026

Laatste update ingediend die voldeed aan QC-criteria

29 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • B04-23-01-T0058

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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