Cutaneous Mastocytoses
Conditions
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.
Interventions
COMBINATION_PRODUCTTopical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
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
Sponsors
Joseph Butterfield
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cutaneous Symptom Relief | 2 weeks | Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin |
| SkinDex-16 Quality of Life Questionnaire | Baseline | This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin Guard 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
Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.: 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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Skin Guard |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Cutaneous Symptom Relief
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skin Guard | Cutaneous Symptom Relief | 0 Participants |
Primary
SkinDex-16 Quality of Life Questionnaire
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Guard | SkinDex-16 Quality of Life Questionnaire | 78 score on a scale |
Primary
SkinDex-16 Quality of Life Questionnaire
This validated questionnaire is a 16-item, participant-reported survey used to assess quality of life impacts due to the participant's skin condition. Scores range from 0 to 6, where 0 is never bothered by the skin condition and 6 is always bothered by the skin condition. Results are summed to produce an overall score, ranging from 0 to 96, where lower scores indicated a higher level of quality of life.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Guard | SkinDex-16 Quality of Life Questionnaire | 75 score on a scale |