Clinical trial NCT04846348: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cutaneous Mastocytoses
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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, 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

Primary outcomes:
measure: Cutaneous Symptom Relief
timeFrame: 2 weeks
measure: SkinDex-16 Quality of Life Questionnaire
timeFrame: Baseline
measure: SkinDex-16 Quality of Life Questionnaire
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joseph Butterfield, MD
role: PRINCIPAL_INVESTIGATOR
References: