What side effects are associated with this type of intervention?

Common treatments for mastocytosis, particularly those targeting mast cells or inflammatory pathways, include topical corticosteroids, antihistamines, and mast cell stabilizers. Known side effects of topical corticosteroids can include skin thinning, irritation, and potential systemic absorption leading to hormonal imbalances. Antihistamines may cause drowsiness, dry mouth, and dizziness. Mast cell stabilizers, such as cromolyn sodium, are generally well-tolerated but can occasionally cause gastrointestinal discomfort and skin irritation. It is important to consult with a healthcare provider to tailor treatment and manage any adverse effects.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved topical treatments for mastocytosis that target mast cells or inflammatory pathways. Treatment for mastocytosis generally involves managing symptoms with antihistamines, corticosteroids, and other medications to control allergic reactions and inflammation. Systemic treatments may include tyrosine kinase inhibitors for more severe cases. The novel topical preparation being studied aims to provide a targeted approach for cutaneous lesions of mastocytosis, potentially offering a new therapeutic option in the future.

What other types of research exist?

Promising novel alternatives for treating mastocytosis in 2024 include: 1) Janus kinase (JAK) inhibitors like delgocitinib, which have shown efficacy in inflammatory skin conditions such as atopic dermatitis. 2) Biologic agents targeting specific interleukins, such as IL-13 inhibitors (e.g., lebrikizumab) and IL-22 antagonists (e.g., fezakinumab), which have demonstrated benefits in reducing inflammation. 3) Probiotics, which have shown potential in modulating immune responses and reducing symptoms in atopic dermatitis, may also offer benefits for mastocytosis patients.

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Topical Cream for Mastocytosis

Phase 2

Waitlist Available

Led By Joseph Butterfield, MD

Research Sponsored by Joseph Butterfield

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include local skin reactions like redness, itching or irritation at the site of application due to the active ingredients in the cream.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cutaneous Symptom Relief

SkinDex-16 Quality of Life Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Skin GuardExperimental Treatment1 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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mastocytosis treatments primarily target mast cells and the inflammatory pathways they activate. Common treatments include mast cell stabilizers, which prevent the release of histamine and other mediators, and antihistamines, which block the effects of histamine on tissues. Topical corticosteroids are also used to reduce local inflammation. These mechanisms are crucial for Mastocytosis patients as they help manage symptoms like itching, redness, and swelling by directly addressing the underlying cellular processes. The novel topical preparation being studied likely aims to enhance these effects by targeting mast cells or specific inflammatory pathways more effectively.

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long-term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.Comparative efficacy of once-daily therapy with inhaled corticosteroid, leukotriene antagonist or sustained-release theophylline in patients with mild persistent asthma.