Study of Diphenhydramine, Famotidine, and Cromolyn Sodium to Reduce Itch from Burn Scars in Adults

What this Trial Is About

Researchers are investigating new ways to reduce itchiness in people with burn scars. This Phase 3 study focuses on whether using medications like diphenhydramine Benadryl, famotidine Pepcid, and cromolyn sodium can lessen the discomfort caused by burn scar itch. The study builds on evidence from other patient groups where similar treatments have helped reduce itch. Participants will be randomly assigned to one of two treatment groups. One group will take oral diphenhydramine along with famotidine capsules twice daily and apply a lotion containing 4% cromolyn sodium twice daily. The other group will take diphenhydramine with placebo capsules and lotion. This double-blind study compares the effects of these two approaches over several months. During the study, participants will be monitored using an itch scale weekly for three months and again at three and six months. Additional assessments include scar appearance, pain levels, quality of life surveys, and activity tracking with a Fitbit. Safety and adherence will be observed throughout, with follow-up visits approximately three and six months after starting treatment. The total participation time can extend up to six months.

Novel Strategies for Reducing Burn Scar Itch