Novel Strategies for Reducing Burn Scar Itch

The University of Texas System (UT)

Status and phase: Enrolling; Phase 3

Conditions: Wound; Itch Scarring; Burn Scar

Treatments: Other: Placebo; Combination Product: Famotidine and 4% topical cromolyn sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT06801626

24-0180

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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).
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

44 participants in 2 patient groups, including a placebo group

PLUS Group

Experimental group

Description:

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)

Treatment:

Combination Product: Famotidine and 4% topical cromolyn sodium

Placebo Group

Placebo Comparator group

Description:

Treatment with active H1 antihistamine plus administration of placebo famotidine and placebo cromolyn sodium.

Treatment:

Other: Placebo