Actively Recruiting
Novel Strategies for Reducing Burn Scar Itch
Led by The University of Texas Medical Branch, Galveston · Updated on 2025-09-24
44
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Medical Branch, Galveston
Lead Sponsor
U
University of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new ways to reduce itchiness in people with burn scars. This Phase 3 study focuses on whether using medications like diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium can lessen the discomfort caused by burn scar itch. The study builds on evidence from other patient groups where similar treatments have helped reduce itch. Participants will be randomly assigned to one of two treatment groups. One group will take oral diphenhydramine along with famotidine capsules twice daily and apply a lotion containing 4% cromolyn sodium twice daily. The other group will take diphenhydramine with placebo capsules and lotion. This double-blind study compares the effects of these two approaches over several months. During the study, participants will be monitored using an itch scale weekly for three months and again at three and six months. Additional assessments include scar appearance, pain levels, quality of life surveys, and activity tracking with a Fitbit. Safety and adherence will be observed throughout, with follow-up visits approximately three and six months after starting treatment. The total participation time can extend up to six months.
CONDITIONS
Brief Title
Novel Strategies for Reducing Burn Scar Itch
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent and is willing and able to follow trial procedures.
- Adults aged 18 to under 80 years.
- Has an itchy burn scar.
You will not qualify if you...
- Failure to obtain consent or unable to return for follow-up assessments.
- Unable to follow the required study assessments.
- Member of a vulnerable class such as prisoners or pregnant participants.
- Any medical condition that increases risk for participation per the investigator's opinion.
- Currently in another interventional clinical trial.
- History of non-compliance or psychiatric conditions affecting study participation.
- Taking cefuroxime, dasatinib, delavirdine, neratinib, pazopanib, risedronate, or tizanidine.
- Has a pre-existing inflammatory or itchy skin disease.
- Currently taking an H2 antihistamine for another reason.
- Age below 18 or 80 and above.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive oral diphenhydramine plus either oral famotidine and topical cromolyn sodium or placebo capsules and lotion to reduce burn scar itch.
Weekly visits for up to 3 months
Duration - 3 months
Participants are assessed for itch and scar impact at 3 and 6 months after starting treatment.
2 visits (in-person) at approximately 3 and 6 months
Trial Site Locations
Total: 1 location
1
University of Texas Medical Branch, Galveston
Galveston, Texas, United States, 77555
Actively Recruiting
Research Team
L
Lindsey Allen, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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