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

Trial Summary

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.

What data supports the effectiveness of the drugs Cromolyn Sodium, Diphenhydramine, and Famotidine for treating burn scars?

Diphenhydramine, an antihistamine, has been shown to reduce skin damage in a rat model of ischemia/reperfusion injury, which is a condition similar to burn injuries. Additionally, a gel containing diphenhydramine has demonstrated a strong antihistaminic effect, which can help with itching, a common issue in burn patients. ^{1 2 3 4 5}

Is the combination of Pepcid and Cromolyn Sodium safe for use in humans?

Cromolyn Sodium is generally used safely in humans for allergic conditions, as it helps prevent allergic reactions by stopping the release of histamine, a chemical that causes inflammation. Diphenhydramine, another component sometimes used with Cromolyn Sodium, is also commonly used as an antihistamine to treat allergies and is considered safe for short-term use. ^{3 4 6 7 8}

How does the drug Pepcid + Cromolyn Sodium for burn scars differ from other treatments?

The combination of Pepcid (Famotidine), Cromolyn Sodium, and Diphenhydramine for burn scars is unique because it combines an antihistamine (Diphenhydramine) and a mast cell stabilizer (Cromolyn Sodium) with an H2 blocker (Famotidine), which is not a standard approach for burn scar treatment. This combination may offer a novel mechanism by potentially reducing inflammation and histamine release, which are not typically targeted in standard burn treatments. ^{9 10 11 12 13}

What is the purpose of this trial?

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

Research Team

Celeste Finnerty, PhD

Principal Investigator

University of Texas Medical Branch, Galveston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 1 Intervention

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Bioavailability and local anesthetic effect of the combination of tyrothricin, fomocain, diphenhydramine and 8-hydroxyquinoline in a gel preparation for burns and wounds]. [2014]

2. Denmark pubmed.ncbi.nlm.nih.gov

Effects of cromolyn on codeine-induced histamine release in vivo. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Prevention of ischemia-reperfusion injury in a rat skin flap model: the role of mast cells, cromolyn sodium, and histamine receptor blockade. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[The antihistaminic effect of a gel for burns and wounds containing tyrothricin, fomocaine, diphenhydramine and 8-hydroxyquinoline (author's transl)]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Severe itching in the patient with burns. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A comparison of the in vivo effects of ketotifen, clemastine, chlorpheniramine and sodium cromoglycate on histamine and allergen induced weals in human skin. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The anti-allergic effects of a cromolyn sodium-chlorpheniramine combination compared to ketotifen in the conjunctival allergen challenge model. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Cromolyn sodium in ocular allergic diseases. [2013]

9. Ukraine pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of preparation lactoprotein with sorbitol in patients with deep and extended burns]. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of three different topical antibacterial dressings on Acinetobacter baumannii-contaminated full-thickness burns in rats. [2013]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Topical treatment of burns using aserbine. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Topical chlorhexidine diphosphanilate (WP-973) in burn wound sepsis. [2019]

13. Austria pubmed.ncbi.nlm.nih.gov

Comparison of the antibacterial effects of a short cationic peptide and 1% silver bioactive glass against extensively drug-resistant bacteria, Pseudomonas aeruginosa and Acinetobacter baumannii, isolated from burn patients. [2018]