火傷の瘢痕のかゆみを減らすための新しい戦略
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Celeste Finnerty, PhD
- 電話番号：409-692-9036
- メール：ccfinner@utmb.edu
研究場所
-
-
Texas
-
Galveston、Texas、アメリカ、77555
- 募集
- University of Texas Medical Branch, Galveston
-
コンタクト：
- Celeste Finnerty, PhD
- 電話番号：409-692-9036
- メール：ccfinner@utmb.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Itch Scale: Visual Analogue Scale Itch (VAS Itch)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Patient and Observer Scar Assessment Scale 3.0
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Celeste Finnerty, PhD、University of Texas Medical Branch, Galveston
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 24-0180
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