Purpose

The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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)
  • Combination Product: Famotidine and 4% topical cromolyn sodium
    Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
Placebo Comparator
Placebo Group
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
  • Combination Product: Famotidine and 4% topical cromolyn sodium
    Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.

Recruiting Locations

University of Texas Medical Branch, Galveston
Galveston, Texas 77555
Contact:
Celeste Finnerty, PhD
409-692-9036
ccfinner@utmb.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Medical Branch, Galveston

Study Contact

Lindsey Allen, RN
409-266-2678
listurm@utmb.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.