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Topical Cream for Mastocytosis

Phase 2

Recruiting

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 baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Awards & highlights

Study Summary

This trial is testing a new topical treatment for mastocytosis, a condition where too many mast cells build up in the skin.

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.Check my eligibility

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.See study design

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 ~ baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 2 weeks, 3 weeks, 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cutaneous symptom relief

SkinDex-16 Quality of Life

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Joseph ButterfieldLead Sponsor

Joseph Butterfield, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus

Media Library

Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04846348 — Phase 2

Mastocytosis Research Study Groups: Skin Guard

Mastocytosis Clinical Trial 2023: Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base Highlights & Side Effects. Trial Name: NCT04846348 — Phase 2

Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04846348 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions available for participants in this clinical trial?

"Yes, this study is still looking for patients to enroll. The trial was first posted on July 26th, 2021 and has been updated most recently on March 11th, 2022 according to the clinicaltrials.gov website"

Answered by AI

If a patient is outside of the age range for this study, can they still participate?

"This clinical trial is open to patients aged 18-80. If you are either under or over that age, there may be other trials more suited for you as this study has 60 openings for patients over 65 and 18 for those under 18."

Answered by AI

What is the total number of participants in this medical study?

"That is correct. The clinicaltrials.gov website has the most recent update on this trial, which was posted on March 11th, 2022. This trial was first posted on July 26th, 2021 and is looking for 10 more participants at 1 location."

Answered by AI

What indications does this medication commonly treat?

"The topical application of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base can help alleviate pain, catarrh, and rhinorrhoea."

Answered by AI

What are the potential dangers associated with using Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base?

"This medication has only been studied in Phase 2 trials, so there is some evidence of safety but not yet efficacy. We gave it a score of 2."

Answered by AI

Are there other scientific studies which have looked at using a similar cream to this one for medical purposes?

"There are 83 active studies investigating the use of Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base., with 20 trials in Phase 3. While most of the trials for Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. are based in West Haven, Connecticut, there are 1784 locations operating studies for Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolam"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Joseph Butterfield 2021. "Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04846348.

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