Systemic mastocytosis with a slow course and involvement of the skin
Conditions
Brief summary
1. Reducing the incidence of symptoms caused by the release of mast cell mediators, mainly anaphylaxis (number of anaphylaxis and flushing/week) 2. Reducing the extent of skin lesions (BSA-Body Surface Area assessed according to the principle Nines Wallace) 3. Reduction of itch severity (VAS) 4. Improving the quality of life (MC-QoL, EORTC QLQ C30) 5. Reducing symptoms of depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Impact Scale)
Detailed description
1. Quality of Life in Mastocytosis (QLMS) Questionnaire, 2. The incidence of life-threatening anaphylactic reactions, 3. Decreased concentration of tryptase, IL4 and IL13 in peripheral blood serum.
Interventions
Sponsors
Medical University Of Gdansk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reducing the incidence of symptoms caused by the release of mast cell mediators, mainly anaphylaxis (number of anaphylaxis and flushing/week) 2. Reducing the extent of skin lesions (BSA-Body Surface Area assessed according to the principle Nines Wallace) 3. Reduction of itch severity (VAS) 4. Improving the quality of life (MC-QoL, EORTC QLQ C30) 5. Reducing symptoms of depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Impact Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of Life in Mastocytosis (QLMS) Questionnaire, 2. The incidence of life-threatening anaphylactic reactions, 3. Decreased concentration of tryptase, IL4 and IL13 in peripheral blood serum. | — |
Countries
Poland
Outcome results
None listed