Clinical trial · Interventional
Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
NCT04846348CI-TRIAL-00076492terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It was difficult to enroll patients during the pandemic. A new oral drug, Avapritinib, has since been approved for systemic mastocytosis. This medication controls skin manifestations of mastocytosis and is more convenient for patients to use.
Summary
Brief summary (as posted)
The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Mastocytoses | Cutaneous Mastocytosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Skin Guard
- description
- 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
- interventionNames
- Combination Product: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
Primary outcomes (3)
- measure
- Cutaneous Symptom Relief
- timeFrame
- 2 weeks
- description
- Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
- measure
- SkinDex-16 Quality of Life Questionnaire
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria * Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease * Male and female patients 18 to 80 years of age * No UVB treatment of the skin for 6 months prior to study entry * No use of topical or systemic corticosteroids for 1 month 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. * Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and * Patients who read and sign an approved informed consent for this study Exclusion criteria * Vulnerable study population * Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months * Regular use of skin lightening agents within 1 month of study entry, including * Topical corticosteroids * Topical bleaching products * Topical retinoids * Use of systemic preparations within 1 month of study entry, including: * Systemic corticosteroids * Systemic cyclosporine, interferon * Systemic acitretin, etretinate, isotretinoin * Systemic methotrexate, * Systemic photoallergic, phototoxic and/or photosensitizing drugs * UV light therapy and sunbathing * Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function * Pregnant or nursing women * Women planning a pregnancy within the study period
References
Publications (0)
Data not yet available
No reference posted for this study.