Topical Cream for Mastocytosis
Trial Summary
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.
What data supports the effectiveness of the topical cream for mastocytosis?
The research indicates that sodium cromolyn, a component of the cream, has been used in various forms for mastocytosis, but its effectiveness is not clearly superior to other treatments. Additionally, disodium cromoglycate, similar to sodium cromolyn, has shown no effect on skin symptoms of cutaneous mastocytosis.12345
Is the topical cream for mastocytosis safe for humans?
How is the topical cream for mastocytosis different from other treatments?
This topical cream is unique because it combines sodium cromolyn, diphenhydramine, and trolamine salicylate in an emollient base, offering a direct application to the skin, which may help manage skin symptoms of mastocytosis. Unlike other treatments that are often oral or systemic, this cream targets the skin directly, potentially providing localized relief.123910
What is the purpose of this trial?
This trial is testing a new cream or ointment for patients with skin lesions caused by mastocytosis. The treatment is applied directly to the skin to help reduce or heal the lesions. Tacrolimus ointment is the first of a new class of treatments for skin conditions.
Research Team
Joseph Butterfield, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
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
Treatment Details
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