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

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. ^{1 2 3 4}

Why 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. ^{2 3 4 5 6}

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

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 for a Trial Participant

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

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

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04846348

Topical Composition Therapy for the Treatment of ... The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10302407/

Guiding Clinical Prescription of Topical Extemporaneous ... The stability of topical extemporaneous compounded SCG formulations can be extended for up to three months at room temperature (25 °C).

3. withpower.com withpower.com/trial/phase-3-mastocytoma-6-2021-2c093?fbclid=IwZXh0bgNhZW0CMTEAAR6Zle44xm7aEtjykw7hkV4__y0uufuANxGNSvxIF_TZehwRTxeVt5tnBiMA8w_aem_6YYQi-KVqI4ERqt0tcjdvQ

Topical Cream for Mastocytosis · Info for Participants Additionally, disodium cromoglycate, similar to sodium cromolyn, has shown no effect on skin symptoms of cutaneous mastocytosis.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/48/NCT04846348/Prot_SAP_000.pdf

Butterfield IND, Topical Composition for Cutaneous ... The primary objective of this study is to assess the effectiveness of twice daily application of trolamine salicylate 10%, sodium cromolyn 5%, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4362676/

Mastocytosis: update on pharmacotherapy and future ... suggest that cromolyn significantly controls GI symptoms and improves overall disease severity even in patients on longstanding cromolyn therapy, suggesting a ...

6. mdpi.com mdpi.com/1999-4923/15/6/1609

Guiding Clinical Prescription of Topical Extemporaneous ... For example, a combination product for topical use containing SCG (5%), diphenhydramine (1%), and trolamine salicylate (10%) in an emollient ...