- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06807021
화상 환자에서 흉터를 완화하기 위해 FS2의 수술 후 사용
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
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Stephanie Recker
- 전화번호: 1-887-557-7722
- 이메일: srecker@nutrasource.ca
연구 연락처 백업
- 이름: Adam Kuttenkeuler
- 전화번호: 113 +1519-341-3367
- 이메일: akuttenkeuler@nutrasource.ca
연구 장소
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T6G 2B7
- 모병
- University of Alberta, Division of Plastic Surgery
-
연락하다:
- Sharada Manchikanti, MD
- 전화번호: 780-407-5203
- 이메일: Sharada.Manchikanti@albertahealthservices.ca
-
수석 연구원:
- Alex Morzycki, MD
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8L 2X2
- 모병
- Centre for Burn Research - Hamilton Health Sciences
-
연락하다:
- Esohe Ogbomo, BSc, MPH
- 전화번호: 40790 905-521-2100
- 이메일: Esohe.Ogbomo@TAARI.CA
-
연락하다:
- Hannah Hamm
- 전화번호: 40790 905-521-2100
- 이메일: Hannah.Hamm@TAARI.CA
-
수석 연구원:
- Marc Jeschke, PHD
-
부수사관:
- Stephanie Chadwick, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Medically able and willing to consent/assent to study requirements
- Male and female burn patients
- 12 to 65 years of age (inclusive)
- 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.
- Have a BMI between 15 and 35 kg/m2 (inclusive)
- Have clinically acceptable results in the safety laboratory tests as deemed by the investigator
- Have full thickness burn injury that required partial thickness skin graft (meshed or sheet) for any location other than the face and genitalia
- Skin graft size is between 50 cm2 and 800 cm2 (post-meshing, if a meshed graft)
- If skin graft is meshed, maximum skin graft expansion ratio is 1:1.5
- Able to apply the IPs as instructed, whether by the participants themselves or their accompanying caregivers
Exclusion Criteria:
- Medically unable to consent to study requirements
- Treatment site(s) (skin graft site) located on the face and genitalia
- 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
- Expected to be medically unstable for the duration of the study period and an additional 1-month thereafter
- Pregnant, or attempting to become pregnant
- 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
- Subjects who had any clinical evidence of severe ongoing or prolonged depression or mental illness within the last year
- Subjects who smoke more than 20 cigarettes a day
- 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
- 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)
- 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
- 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
- Subjects with a history of abnormal keloid scarring
- 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
- 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)
- A history of radiotherapy to the study scar area
- Subjects who have known sensitivity to any components of the IPs
- Any other diagnosis, condition, physical or geographical limitation with the participant
공부 계획
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
스폰서
수사관
- 연구 책임자: Carlos Camozzi, MD, PHD, BirchBioMed Inc.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B04-23-01-T0058
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .