Novas estratégias para reduzir a cicatriz de queimaduras
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Celeste Finnerty, PhD
- Número de telefone: 409-692-9036
- E-mail: ccfinner@utmb.edu
Locais de estudo
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Texas
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Galveston, Texas, Estados Unidos, 77555
- Recrutamento
- University of Texas Medical Branch, Galveston
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Contato:
- Celeste Finnerty, PhD
- Número de telefone: 409-692-9036
- E-mail: ccfinner@utmb.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Comparador de Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Itch Scale: Visual Analogue Scale Itch (VAS Itch)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The Patient and Observer Scar Assessment Scale 3.0
Prazo: 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
|
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Brisbane Burn Scar Impact Panel (BBSIP)
Prazo: 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
|
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PROMIS-29
Prazo: 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)
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Pain scale: Visual Analog Scale for Pain (VAS Pain)
Prazo: 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)
|
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Patient Global Impression of Change (PGIC)
Prazo: 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)
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Participants Activity with Fitbit
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Celeste Finnerty, PhD, University of Texas Medical Branch, Galveston
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações de pele
- Doenças de pele
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Sinais e sintomas
- Ferimentos e Lesões
- Queimaduras
- Prurido
- Compostos de enxofre
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Pyrans
- Tiazóis
- Azoles
- Benzopyrans
- Cromônios
- Famotidina
- Cromolina Sódica
Outros números de identificação do estudo
- 24-0180
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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