Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions

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.

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.