화상 흉터 가려움증을 줄이기위한 새로운 전략
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
연구 개요
상세 설명
The purpose of this study is to examine the effect of a new approach to treating burn scar itch. In other patient populations experiencing itch, H2 antihistamines and/or topically applied cromolyn sodium have decreased itch. We believe that these medications will reduce itch from burn scars. To test this idea, the investigators will compare two methods of treating itch: 1) recommended oral diphenhydramine (Benadryl) with placebo capsule and placebo lotion and 2) recommended oral diphenhydramine (Benadryl) with administration of oral famotidine (Pepcid) and topically applied cromolyn sodium.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Celeste Finnerty, PhD
- 전화번호: 409-692-9036
- 이메일: ccfinner@utmb.edu
연구 장소
-
-
Texas
-
Galveston, Texas, 미국, 77555
- 모병
- University of Texas Medical Branch, Galveston
-
연락하다:
- Celeste Finnerty, PhD
- 전화번호: 409-692-9036
- 이메일: ccfinner@utmb.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Participants must meet all the inclusion criteria in order to be eligible to participate in the study.
- Participant has provided informed consent in a manner approved by the IRB and is willing and able to comply with the trial procedures.
- Adults: ≥18 to <80 years of age.
- Has an itchy burn scar.
Exclusion Criteria:
Participants meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Failure to obtain consent or unable to return for follow up assessments.
- Patient is unable to follow the protocol required assessments.
- Member of a vulnerable class (e.g., prisoners, pregnant participant, etc.).
- Any medical condition that, in the opinion of the investigator or physician, would place the participant at increased risk for participation.
- Concurrent participation in another interventional clinical trial (to avoid confounding factors that may influence outcomes).
- History of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would, in the opinion of the investigator, make it difficult for the participant to comply with the study procedures or follow the investigators instructions.
- Age < 18 or ≥ 80 years.
- Taking one of the following medications: cefuroxime, dasatinib, delavirdine, neratinib, pazopanib, risedronate, or tizanidine.
- Has a pre-existing inflammatory or itchy skin disease.
- Is taking an H2 antihistamine for another indication.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PLUS Group
Treatment with active H1 antihistamine and administered active H2 antihistamine and using cromolyn sodium PLUS (-PLUS active H1 antihistamine, plus active famotidine and active cromolyn sodium) |
Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily. |
|
위약 비교기: Placebo Group
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium. |
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Itch Scale: Visual Analogue Scale Itch (VAS Itch)
기간: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
|
Patients will score the severity of itch on the scale provided at study start, once weekly for 3 months, at the 3-month visit, and again at study end (6 months). Patients will rate their itch from 0 to 10. to measure the intensity of itchiness, where a patient marks a point on a line to indicate how severe their itch is, with zero representing "no itch" and 10 representing "worst imaginable itch." A higher score means a worse outcome. |
baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Patient and Observer Scar Assessment Scale 3.0
기간: baseline, and at clinic visit approximately 3 months (±15 days) after study start
|
The Patient and Observer Scar Assessment Scale (POSAS) is an established scale for assessing scars by both the patient and the observer. The overall opinion of the scar is reported on a scale of 1-10, with 1 being normal skin and 10 being the worst scar. (POSAS 3.0) will be filled out by the participant and a clinical observer to evaluate scar severity/quality. |
baseline, and at clinic visit approximately 3 months (±15 days) after study start
|
|
Brisbane Burn Scar Impact Panel (BBSIP)
기간: baseline, and at clinic visit approximately 3 months (±15 days) after study start
|
BBSIP is a patient-reported outcome measure developed in consultation with burn survivors that takes approximately 10 minutes to complete; the specificity of this comprehensive questionnaire allows detection of changes in quality of life related to burn hypertrophic scar. Higher scores indicate a worse outcome. |
baseline, and at clinic visit approximately 3 months (±15 days) after study start
|
|
PROMIS-29
기간: baseline, and at clinic visit approximately 3 months after study start (±15 days)
|
This questionnaire will be administered to determine whether the effects of treatment impact quality of life as reported by the patient. |
baseline, and at clinic visit approximately 3 months after study start (±15 days)
|
|
Pain scale: Visual Analog Scale for Pain (VAS Pain)
기간: baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
|
The VAS pain score is a simple and effective method used to measure patients' pain levels. This method is typically represented by a line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain. Patients are asked to mark a point on the line that corresponds to their level of pain. |
baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)
|
|
Patient Global Impression of Change (PGIC)
기간: baseline, and at clinic visit approximately 3 months after study start (±15 days)
|
A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=not present, 2=mild, 3=moderate, 4=severe, and 5=very severe. A higher score indicates a worse outcome. |
baseline, and at clinic visit approximately 3 months after study start (±15 days)
|
|
Participants Activity with Fitbit
기간: Month 1, 2, 3 (+15 days, each timepoint)
|
Overall activity: To be captured via Fitbit on a daily basis to gauge overall activity. These data will be correlated with the itch and pain scales, as reduced activity is associated with pain and/or itch. |
Month 1, 2, 3 (+15 days, each timepoint)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Celeste Finnerty, PhD, University of Texas Medical Branch, Galveston
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- 24-0180
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
미국에서 제조되어 미국에서 수출되는 제품
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. .