Apomorphine-induced Skin Reactions, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Apomorphine, Infusion, Skin reactions, Subcutaneous nodules, Hydrocortisone, Massage, Dilution
Brief summary
Skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently and interfere with the absorption of apomorphine. The histopathology of apomorphine-induced skin reactions is poorly understood. Therefore treatment options are limited and suggestive. Objective: to investigate the efficacy of four treatments including massage, dilution of apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous administered hydrocortisone, in Parkinson's disease patients with apomorphine-induced skin reactions.
Interventions
DRUGApomorphine 0.25% (2.5mg/ml)
Apomorphine 0.5% (5mg/ml) will be diluted to 0.25% (2.5mg/ml) by the addition of the same volume physiological saline (NaCl 0.9%).
DEVICEMassage with a spiky ball
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
DRUGSubcutaneous hydrocortisone 10mg
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
Sponsors
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female and male subjects aged ≥30; * Diagnosis of idiopathic Parkinson's disease of \>3 years' duration, defined by the United Kingdom (UK) Brain Bank criteria, with the exception of \>1 affected relative being allowed, without any other known or suspected cause of Parkinsonism (Gibb & Lees, 1988); * Treatment with continuous subcutaneous apomorphine infusion; * Having apomorphine-induced skin reactions (i.e. erythema, swelling and/or nodule formation); * Male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study, if sexually active; * Subjects considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgement of the investigator.
Exclusion criteria
* High suspicion of other parkinsonian syndromes; * History of respiratory depression; * Hypersensitivity to hydrocortisone or any excipients of the medicinal product; * Concomitant therapy with histamine antagonist; * Known with Cushing's disease or hypercortisolism * Any medical condition that is likely to interfere with an adequate participation in the study including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months; * Pregnant and breastfeeding women; * Current infectious disease with fever at the time of investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes on global perceived effect scale | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in histological skin tissue characteristics | 14 days | Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes. |
| Changes in nodule size (diameter) | 14 days | — |
| Changes in erythema size (diameter) | 14 days | — |
| Personal or family history of atopic constellation | 14 days | Assessed with a questionnaire |
| Personal or family history of allergies | 14 days | Assessed with a questionnaire |
| Eosinophilia | 14 days | Defined as increased absolute eosinophil count |
Other
| Measure | Time frame | Description |
|---|---|---|
| Liver enzymes | 14 days | aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT) |
Countries
Netherlands
Outcome results
None listed