이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

화상 환자에서 흉터를 완화하기 위해 FS2의 수술 후 사용

2026년 9월 29일 업데이트: Birch BioMed Inc

피부 이식 및 기증자 부위의 피부 흉터 및 기증자 부위의 안전성 및 완화를 평가하는 이중 블라인드, 무작위 차량 제어 연구에서 화합물 FS2를 억제하는 섬유증의 수술 후 국소 투여

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.

연구 개요

상세 설명

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)

연구 유형

중재적

등록 (추정된)

70

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Alberta
      • Edmonton, Alberta, 캐나다, T6G 2B7
    • Ontario
      • Hamilton, Ontario, 캐나다, L8L 2X2
        • 모병
        • Centre for Burn Research - Hamilton Health Sciences
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Marc Jeschke, PHD
        • 부수사관:
          • Stephanie Chadwick, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

12년 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Skin Grafted wound

The wound site (injury)

Without FS2

FS2 in pharmaceutical compounding base

실험적: Donor Skin Graft Harvest wound

A Surgical wound

Without FS2

FS2 in pharmaceutical compounding base

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Scar condition of the skin grafted wound on Day 90 as assessed by VSS
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Scar condition of the donor skin graft harvest site on Day 90 as assessed by VSS
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Scar size(cm2) at the skin grafted wound on Day 28, Day 60 and Day 90 as assessed by photographs
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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 (%)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 책임자: Carlos Camozzi, MD, PHD, BirchBioMed Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 3월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2025년 1월 22일

QC 기준을 충족하는 최초 제출

2025년 1월 31일

처음 게시됨 (실제)

2025년 2월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

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아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다