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Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

Primary Purpose

Cutaneous Mastocytoses

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
Sponsored by
Joseph Butterfield
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Mastocytoses

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, isoretinoin
    • 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

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin Guard

Arm 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

Outcomes

Primary Outcome Measures

Cutaneous symptom relief
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
SkinDex-16 Quality of Life
Change in Skindex-16 score. Skindex-16 is a validated measurement of the effects of skin diseases on patients' quality of life

Secondary Outcome Measures

Full Information

First Posted
April 12, 2021
Last Updated
March 13, 2023
Sponsor
Joseph Butterfield
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1. Study Identification

Unique Protocol Identification Number
NCT04846348
Brief Title
Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
Official Title
An Open-Label Pilot Study to Evaluate the Effectiveness and Tolerability of a Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Butterfield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Mastocytoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin Guard
Arm Type
Experimental
Arm 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
Intervention Type
Combination Product
Intervention Name(s)
Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
Other Intervention Name(s)
Skin Guard
Intervention Description
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).components: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor
Primary Outcome Measure Information:
Title
Cutaneous symptom relief
Description
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
Time Frame
4 weeks
Title
SkinDex-16 Quality of Life
Description
Change in Skindex-16 score. Skindex-16 is a validated measurement of the effects of skin diseases on patients' quality of life
Time Frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, isoretinoin 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Butterfield, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph H Butterfield, M.D.
Phone
507-284-3783
Email
butterfield.joseph@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

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