Novel Strategies for Reducing Burn Scar Itch
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Medical Branch, Galveston
About this trial
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Famotidine and 4% topical cromolyn sodium
Combination productPatients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
Placebo
Other interventionTreatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: PLUS GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Itch Scale: Visual Analogue Scale Itch (VAS Itch)
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.
Time frame
baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start dateSecondary outcomes
1
The Patient and Observer Scar Assessment Scale 3.0
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.
Time frame
baseline, and at clinic visit approximately 3 months (±15 days) after study start2
Brisbane Burn Scar Impact Panel (BBSIP)
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.
Time frame
baseline, and at clinic visit approximately 3 months (±15 days) after study start3
PROMIS-29
This questionnaire will be administered to determine whether the effects of treatment impact quality of life as reported by the patient.
Time frame
baseline, and at clinic visit approximately 3 months after study start (±15 days)4
Pain scale: Visual Analog Scale for Pain (VAS Pain)
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.
Time frame
baseline, and at clinic visit approximately 3 months and 6 months after study start (±15 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
University of Texas
Collaborator
Source ClinicalTrials.gov