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Hydroxychloroquine in isolated cutaneous mastocytosis patients or indolent systemic mastocytosis with associated skin involvement patients: proof of concept study (HCQMa)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518594-33-00
Acronym
RC31/19/0504
Enrollment
30
Registered
2024-10-22
Start date
2021-11-18
Completion date
Unknown
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mastocytosis

Brief summary

The primary endpoint of this study is the change of mast cell activation symptoms as pruritus and/or flushes between the start of treatment and 12 months later.

Detailed description

- The difference on mast cell mass between the start of treatment and 12 months later, The difference of other mast cell activation symptoms such as diarrhea, pollakiuria, arthralgia and discomfort between the start of treatment and 12 months later., Tolerance by clinical examination and if necessary paraclinical according to the investigator's decision; tolerance will be assessed during the study period, The correlation of the effectiveness of treatment with the hydroxychloroquine and level of serum HCQ

Interventions

DRUGcomprimé pelliculé

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the change of mast cell activation symptoms as pruritus and/or flushes between the start of treatment and 12 months later.

Secondary

MeasureTime frame
- The difference on mast cell mass between the start of treatment and 12 months later, The difference of other mast cell activation symptoms such as diarrhea, pollakiuria, arthralgia and discomfort between the start of treatment and 12 months later., Tolerance by clinical examination and if necessary paraclinical according to the investigator's decision; tolerance will be assessed during the study period, The correlation of the effectiveness of treatment with the hydroxychloroquine and level of serum HCQ

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026