Topical Cream for Mastocytosis

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Joseph Butterfield

Must not be taking: Corticosteroids, Cyclosporine, Retinoids, others

Disqualifiers: UVB exposure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

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. ^{1 2 3 4 5}

Is the topical cream for mastocytosis safe for humans?

Cromolyn sodium, one of the ingredients in the topical cream, has been used in humans for allergic and mast-cell related conditions, suggesting it is generally safe. However, specific safety data for the exact combination of ingredients in the cream is not available in the provided research. ^{3 5 6 7 8}

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. ^{1 2 3 9 10}

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

No UVB treatment of the skin for 6 months prior to study entry

Good general health as confirmed by medical history

Female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence.

Exclusion Criteria

Women planning a pregnancy within the study period

You have been exposed to UVB radiation on your skin in the past 6 months.

Pregnant or nursing women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a topical composition therapy for the treatment of cutaneous lesions of mastocytosis

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base

Trial Overview The study is testing a new topical cream combining sodium cromolyn, diphenhydramine, and trolamine salicylate for treating skin lesions caused by mastocytosis to see if it's effective and tolerable.

Participant Groups

Group I: Skin Guard Experimental Treatment 1 Intervention

Skin cream combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor

Who Is Running the Clinical Trial?

Joseph Butterfield

Lead Sponsor

Trials

1

Recruited

1+

References

1. England pubmed.ncbi.nlm.nih.gov

Oral and inhaled sodium cromoglicate in the management of systemic mastocytosis: a case report. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of cutaneous mastocytosis. [2017]

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

Comparison of the therapeutic efficacy of cromolyn sodium with that of combined chlorpheniramine and cimetidine in systemic mastocytosis. Results of a double-blind clinical trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The effect of disodium cromoglycate and ketotifen on the excretion of histamine and N tau-methylimidazole acetic acid in urine of patients with mastocytosis. [2019]

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

Improved bioavailability of cromolyn sodium using inhaled PA101 delivered via eFlow® nebulizer. [2021]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cromolyn Sodium differentially regulates human mast cell and mouse leukocyte responses to control allergic inflammation. [2022]

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

Evidence questioning cromolyn's effectiveness and selectivity as a 'mast cell stabilizer' in mice. [2023]

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

Oral disodium cromoglycate in the treatment of systemic mastocytosis. [2013]

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

The treatment of mastocytosis: an overview. [2006]