Topical Cream for Mastocytosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new skin cream for treating skin lesions caused by mastocytosis, a condition where too many mast cells accumulate in the skin. The cream combines three ingredients: one blocks histamine, another reduces inflammation, and a third prevents mast cells from releasing their contents. Individuals with confirmed skin mastocytosis who have not recently used certain skin treatments might be eligible to join. The trial aims to determine if this cream is effective and easy to tolerate. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, such as topical or systemic corticosteroids, and other systemic preparations like cyclosporine and methotrexate, at least 1 month before joining. If you're on these medications, you'll need to stop them before participating.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that the topical cream for mastocytosis, containing sodium cromolyn, diphenhydramine, and trolamine salicylate, appears safe. Sodium cromolyn prevents allergic reactions by stopping certain cells from releasing chemicals. Diphenhydramine, an antihistamine, reduces itching and swelling. Trolamine salicylate reduces inflammation.
Most people tolerate these ingredients well when applied to the skin. Side effects are usually mild and may include skin irritation or redness at the application site. As this study is in an early phase, the main focus is on ensuring the cream's safety and observing reactions. Although the cream is still under testing, each ingredient has been used in other products, suggesting it might be safe for most people.1234Why do researchers think this study treatment might be promising?
Researchers are excited about this new topical cream for mastocytosis because it combines three active ingredients that work together in a unique way. Unlike standard treatments, which often focus on oral medications to manage symptoms, this cream directly targets the skin, where mastocytosis symptoms often manifest. Sodium cromolyn in the cream inhibits mast cell degranulation, diphenhydramine acts as an antihistamine, and trolamine salicylate reduces inflammation. This targeted, multi-faceted approach has the potential to provide more effective and localized relief, minimizing systemic side effects often seen with oral treatments.
What evidence suggests that this topical cream could be an effective treatment for mastocytosis?
Research has shown that sodium cromolyn, an ingredient in the topical cream studied in this trial, helps manage mastocytosis symptoms by preventing certain cells from releasing inflammation-causing substances. However, disodium cromoglycate, a similar compound, has not been effective for skin symptoms of cutaneous mastocytosis. Diphenhydramine, another ingredient, is an antihistamine that reduces itching and discomfort. Trolamine salicylate, also in the cream, acts as an anti-inflammatory, reducing swelling and pain. While each ingredient offers benefits, the trial continues to study the cream's overall effectiveness in treating skin lesions from mastocytosis.23456
Who Is on the Research Team?
Joseph Butterfield, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Adults aged 18-80 with biopsy-proven cutaneous mastocytosis can join this trial. Women must not be pregnant, plan to become pregnant, or breastfeed and should use effective birth control. Participants shouldn't have had UVB skin treatment or used corticosteroids recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a topical composition therapy for the treatment of cutaneous lesions of mastocytosis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph Butterfield
Lead Sponsor