Novel Strategies for Reducing Burn Scar Itch

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT06801626
Phase
PHASE3
Status
Recruiting
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Conditions

  • Burn Scar
  • Itch Scarring
  • Wound

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Famotidine and 4% topical cromolyn sodium — COMBINATION_PRODUCT
    Patients will be instructed to take a 20mg famotidine capsule twice daily, and to use the lotion (4% cromolyn sodium) twice daily.
  • Placebo — OTHER
    Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Study Details

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

Key Dates

Start date
Mar 1, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Nov 1, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)
  • Placebo Comparator: Placebo Group
    Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Primary Outcome Measure

Itch Scale: Visual Analogue Scale Itch (VAS Itch) [ Time Frame: baseline, weekly for 3 months, at 3 and 6 months (+/-15 days each timepoint) after start date ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical Branch, GalvestonGalvestonTexas77555
Celeste Finnerty, PhD
[email protected]
409-692-9036

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By research site
University of Texas Medical Branch, Galveston· Galveston, TX

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