A Phase 3 interventional study of Famotidine and 4% topical cromolyn sodium and Placebo in Burn Scar, Itch Scarring and Wound, sponsored by The University of Texas Medical Branch, Galveston. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 3, Interventional, and Treatment
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 44 is close to the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 257 studies on the registry; 38 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Compared within Burns, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all the inclusion criteria in order to be eligible to participate in the study.
Exclusion Criteria:
Participants meeting any of the exclusion criteria at baseline will be excluded from study participation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
Other: Placebo
Drug pages: Famotidine · Cromolyn
Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
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 date
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 start
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 start
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)
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)
Patient Global Impression of Change (PGIC)
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.
Time frame: baseline, and at clinic visit approximately 3 months after study start (±15 days)
Participants Activity with Fitbit
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.
Time frame: Month 1, 2, 3 (+15 days, each timepoint)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Famotidine · Cromolyn
The University of Texas Medical Branch, Galveston →