Trial · NCT05084872
Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients
NCT05084872, Phase 2, Phase 3, Unknown, University Hospital, Toulouse
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients. Trials, record NCT05084872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05084872
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients
- NCT number
- NCT05084872
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 30 participants, estimated
- Lead sponsor
- University Hospital, Toulouse
- Conditions
- Mastocytosis
- Interventions
- Hydroxychloroquine
- First posted
- 2021-10-20
- Last updated
- 2021-10-20
- Other registries' IDs
- eudract:2020-003268-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of mast cell activation symptoms | 12 month | The primary endpoint of this study is the change of mast cell activation symptoms as pruritus between the start of treatment and 12 months later. Skin pruritus will be assessed by the visual analogue scale from 0 to 10 at each visit. |
| Primary | Change of mast cell activation symptoms | 12 month | The primary endpoint of this study is the change of mast cell activation symptoms as flushes between the start of treatment and 12 months later. The skin flush will be evaluated according to the absolute number of flushes / week at each visit |
| Secondary | Difference on mast cell burden - serum tryptase level | 12 month | The difference on mast cell burden between the start of treatment and 12 months later will be evaluated by variation of the level serum tryptase l expressed in μg / L. |
| Secondary | Difference on skin mast cell burden - mast cells/mm² | 12 month | The difference on mast cell burden between the start of treatment and 12 months later will be assessed by variation of the number of mast cells / mm² identified on the skin biopsies. |
| Secondary | Difference of mast cell activation symptoms : diarrhea | 12 month | The difference of diarrhea between the start of treatment and 12 months later evaluated by the absolute number of stools / day for diarrhea |
| Secondary | Difference of mast cell activation symptoms : pollakiuria | 12 month | The difference of pollakiuria between the start of treatment and 12 months later assessed by the absolute number of urinations / day for pollakiuria. |
| Secondary | Difference of mast cell activation symptoms : arthralgia | 12 month | The difference of arthralgia between the start of treatment and 12 months later evaluated by the absolute number of painful joints / day and the intensity of joint pain assessed by the visual analogue scale from 0 to 10 for arthralgia. |
| Secondary | Difference of mast cell activation symptoms : discomfort | 12 month | The difference of discomfort between the start of treatment and 12 months later evaluated by the absolute number of faintness / week |
| Secondary | The safety of hydroxychloroquine treatment. | 12 month | The safety of hydroxychloroquine treatment will be done by evaluation of adverse events |
| Secondary | effectiveness of treatment | 12 month | The correlation between the efficacy of treatment with the hydroxychloroquine and level of serum HCQ will be performed by the Bland-Altman test. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT05084872
GET https://conductscience.org/api/trials/v1/NCT05084872/registered