Trial · NCT04846348
Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
NCT04846348, Phase 2, Terminated, Joseph Butterfield; results first posted 2024-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis. Trials, record NCT04846348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04846348
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis
- NCT number
- NCT04846348
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Joseph Butterfield
- Conditions
- Cutaneous Mastocytoses
- Interventions
- Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.
- First posted
- 2021-04-15
- Last updated
- 2024-04-25
- Results first posted
- 2024-04-25
- Limitations and caveats
It was difficult to enroll patients during the pandemic. Additionally, a new oral drug, Avapritinib, has since been approved for systemic mastocytosis. This medication controls skin manifestations of mastocytosis and is more convenient for patients to use.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cutaneous Symptom Relief | 2 weeks | Number of participants who achieve complete resolution or near-complete clearing of cutaneous symptoms of treated, involved skin |
| Primary | 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. |
| Primary | SkinDex-16 Quality of Life Questionnaire | 2 weeks | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cutaneous Symptom Relief | 2 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | SkinDex-16 Quality of Life Questionnaire | Baseline | score on a scale | NUMBER | |
| PRIMARY | SkinDex-16 Quality of Life Questionnaire | 2 weeks | score on a scale | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cutaneous Symptom Relief | Skin Guard | 0 | Participants | ||
| SkinDex-16 Quality of Life Questionnaire | Skin Guard | 78 | score on a scale | ||
| SkinDex-16 Quality of Life Questionnaire | Skin Guard | 75 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Skin Guard | 1 | |
| Overall Study | COMPLETED | Skin Guard | 1 | |
| Overall Study | NOT COMPLETED | Skin Guard | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Skin Guard | 0 | 1 |
| Total, other adverse events | Skin Guard | 0 | 1 |
| Total, serious adverse events | Skin Guard | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04846348
GET https://conductscience.org/api/trials/v1/NCT04846348/registered