Pepcid + Cromolyn Sodium for Burn Scars

Overseen By Lindsey Allen, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Cefuroxime, Dasatinib, others

Disqualifiers: Pregnancy, Psychiatric condition, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of medications—diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium—can reduce the itchiness of burn scars. Participants will receive either the active treatment or a placebo. One group gets the actual medications, while the other receives something that looks the same but contains no active drugs. The goal is to determine if these medications can make living with burn scars more comfortable. People with itchy burn scars might be a good fit for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including cefuroxime, dasatinib, delavirdine, neratinib, pazopanib, risedronate, tizanidine, and any H2 antihistamines used for other reasons.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cromolyn sodium is generally safe, particularly for treating allergies. It prevents the release of histamine, a chemical that causes allergy symptoms. Famotidine, known by the brand name Pepcid, is often used for stomach issues and is well-tolerated by most people. Diphenhydramine, or Benadryl, is a common antihistamine used to relieve allergy symptoms and is considered safe when used as directed.

The study is in a late phase of clinical trials, indicating that the treatments have shown good safety in earlier tests. These medicines are all approved for other conditions, suggesting they are generally well-tolerated. However, like any medication, side effects can occur. Participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Pepcid (famotidine) combined with cromolyn sodium to treat burn scars because it introduces a new way of targeting inflammation and histamine response, which are crucial in scar formation. Unlike standard treatments, which often focus on moisturizing or reducing scar tissue through physical methods like laser therapy, this approach uses famotidine, an H2 antihistamine, along with cromolyn sodium to stabilize mast cells and reduce histamine release. This dual action targets the root causes of scar formation, potentially leading to more effective reduction in scar severity and faster healing.

What evidence suggests that this trial's treatments could be effective for reducing burn scar itch?

Research has shown that certain medicines, such as diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium, might help reduce itchiness in burn scars. In this trial, participants in the PLUS Group will receive a combination of active H1 antihistamine (diphenhydramine), active famotidine, and active cromolyn sodium to evaluate whether using all three treatments together is more effective in reducing itchiness. Meanwhile, the Placebo Group will receive an active H1 antihistamine with placebo famotidine and placebo cromolyn sodium. Early results suggest that combining these treatments might be more effective than using each one separately. ^{1 2 4 5 6}

Who Is on the Research Team?

Celeste Finnerty, PhD

Principal Investigator

University of Texas Medical Branch, Galveston

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 who have itchy burn scars. Participants must understand and agree to the study's procedures, provide informed consent as approved by an ethics board, and be willing to follow the trial guidelines.

Inclusion Criteria

I meet all the required conditions to join the study.

I have signed the consent form and can follow the study's procedures.

I have an itchy burn scar.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active H1 antihistamine with active H2 antihistamine and cromolyn sodium or active H1 antihistamine with placebo famotidine and placebo cromolyn sodium

6 months

Weekly assessments for 3 months, clinic visits at 3 and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cromolyn Sodium
• Diphenhydramine
• Famotidine

Trial Overview The study investigates if a combination of diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium can reduce itchiness in burn scars. The effectiveness of these medications will be compared during the trial.

How Is the Trial Designed?

Group I: PLUS Group Experimental Treatment 1 Intervention

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)

Group II: Placebo Group Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Published Research Related to This Trial

In a study of discharged burn patients, 87% reported persistent itching, with an average severity score of 7.6 out of 10, indicating that itching is a common and significant issue after burn injuries.

The antihistamines Benadryl, Atarax, and Polyhist Forte provided complete relief for only 20% of patients, with no significant differences in effectiveness among the three medications, suggesting that while they may help, they are not fully effective for most patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe itching in the patient with burns. Vitale, M., Fields-Blache, C., Luterman, A.[2019]

Citations

1. withpower.com withpower.com/trial/pepcid-cromolyn-sodium-for-burn-scars-7b4db

Pepcid + Cromolyn Sodium for Burn Scars The antihistamines Benadryl, Atarax, and Polyhist Forte provided complete relief for only 20% of patients, with no significant differences in effectiveness ...

2. utmb.trialstoday.org utmb.trialstoday.org/trial/NCT06801626

Novel Strategies for Reducing Burn Scar Itch The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch.

3. withpower.com withpower.com/clinical-trials/for-scar

Top Scar Clinical Trials | Power The purpose of the study is to see whether using diphenhydramine (Benadryl), famotidine (Pepcid), and cromolyn sodium will decrease burn scar itch. Pivotal ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/8329794/

Oral agents in the management of urticaria: patient ... Our results suggest that patients receiving diphenhydramine are more satisfied with their treatment than are patients receiving famotidine or cromolyn sodium.

5. utmb.trialstoday.org utmb.trialstoday.org/

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

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9142134/

Pharmaceutical Prophylaxis of Scarring with Emphasis on ... Here we present a survey of preclinical and clinical studies of experimental pharmaceuticals tested for scar prophylaxis, with an emphasis on burns.