A Phase 2 interventional study of Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base. in Cutaneous Mastocytoses, sponsored by Joseph Butterfield. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Joseph Butterfield · Phase 2, Interventional, and Treatment
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.
75 studies on the registry are indexed under Mastocytosis; 16 are open to participants now.
This study's enrollment of 1 is below the median of 30 across 41 interventional studies indexed under Mastocytosis.
Browse Mastocytosis studies →This is the only study on the registry with Joseph Butterfield as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Regular use of skin lightening agents within 1 month of study entry, including
Use of systemic preparations within 1 month of study entry, including:
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
Combination Product: 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
Also known as: Skin Guard
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
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
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
| Milestone | Skin Guard |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin
| Participants | Skin Guard |
|---|---|
| Cutaneous Symptom Relief | 0 |
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.
| score on a scale | Skin Guard |
|---|---|
| SkinDex-16 Quality of Life Questionnaire | 78 |
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.
| score on a scale | Skin Guard |
|---|---|
| SkinDex-16 Quality of Life Questionnaire | 75 |
Collected over Adverse events were collected for each participant from enrollment until last visit, for approximately two weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Skin Guard | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Skin Guard |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Skin Guard |
|---|---|
| Female | 1 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Skin Guard |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Skin Guard |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Skin Guard |
|---|---|
| United States | 1 |
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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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