NCT06801626

Novel Strategies for Reducing Burn Scar Itch

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
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.
OTHER	Placebo	Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-31
• Completion: 2027-11-01
• First posted: 2025-01-30
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States