New methods to reduce itching from burn scars
Novel Strategies for Reducing Burn Scar Itch
PHASE3 · The University of Texas Medical Branch, Galveston · NCT06801626
This study is testing whether diphenhydramine, famotidine, and cromolyn sodium can help adults with burn scars feel less itchy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Texas Medical Branch, Galveston (other) |
| Drugs / interventions | dasatinib, neratinib |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT06801626 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of diphenhydramine, famotidine, and cromolyn sodium in alleviating itch associated with burn scars. Participants will be divided into two groups to compare the effects of oral diphenhydramine with either a placebo or with famotidine and topical cromolyn sodium. The goal is to determine if these medications can significantly reduce itchiness in adults suffering from burn scars. The study is designed to provide insights into new treatment options for this common and distressing symptom.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have an itchy burn scar.
Not a fit: Patients with medical conditions that increase their risk or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment for patients suffering from itch due to burn scars.
How similar studies have performed: Previous studies have shown that similar medications can reduce itch in other patient populations, suggesting potential success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Galveston, Texas
- University of Texas Medical Branch, Galveston — Galveston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Celeste Finnerty, PhD — University of Texas Medical Branch, Galveston
- Study coordinator: Lindsey Allen, RN
- Email: listurm@utmb.edu
- Phone: 409-266-2678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Burn Scar, Itch Scarring, Wound, Itch, Burn, Diphenhydramine, Famotidine