Burn ScarPhase 3NCT06801626
Novel Strategies for Reducing Burn Scar Itch
A Phase 3 study testing Famotidine and 4% topical cromolyn sodium in people with Burn Scar and Itch Scarring, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burn Scar, Itch Scarring, Wound
- What is being tested?
- Famotidine and 4% topical cromolyn sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 1 Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Celeste Finnerty, PhD, 409-692-9036, ccfinner@utmb.edu
About this study
The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.
Read the 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.
- Conditions
- Burn Scar, Itch Scarring, Wound
- Being tested
- Famotidine and 4% topical cromolyn sodium, Placebo
- Keywords
- Itch, Burn, Diphenhydramine, Famotidine
- Medical subject headings
- Wounds and Injuries, Pruritus, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Famotidine and 4% topical cromolyn sodiumCombination product
Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
PlaceboOther
Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.
| Study group | Role | What they receive |
|---|---|---|
| PLUS Group | Experimental | 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) Receives: Combination Product: Famotidine and 4% topical cromolyn sodium |
| Placebo Group | Placebo comparator | Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 1, 2, 3 (+15 days, each timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Celeste Finnerty, PhD, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801626
- Sponsor's protocol ID
- 24-0180
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No