Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

University Medical Center Groningen (UMCG)

Status and phase: Terminated; Phase 2

Conditions: Apomorphine-induced Skin Reactions; Parkinson's Disease

Treatments: Drug: Hydrocortisone cream 1%; Drug: Apomorphine 0.25% (2.5mg/ml); Device: Massage with a spiky ball; Drug: Subcutaneous hydrocortisone 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02230930

46934

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Massage with a spiky ball

Active Comparator group

Description:

Subjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days.

Treatment:

Device: Massage with a spiky ball

Hydrocortisone cream 1%

Active Comparator group

Description:

Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.

Treatment:

Drug: Hydrocortisone cream 1%

Subcutaneous hydrocortisone 10mg

Active Comparator group

Description:

Subjects are instructed to administer subcutaneous hydrocortisone (Solu-Cortef 10mg) prior to apomorphine via the subcutaneous infusion line which is used for administration of apomorphine, for 14 days.

Treatment:

Drug: Subcutaneous hydrocortisone 10mg

Apomorphine 0.25% (2.5mg/ml)

Active Comparator group

Description:

Subjects are instructed to dilute apomorphine 0.5% (5mg/ml) with the same volume of physiologic saline (NaCl 0.9%) to 0.25% (2.5mg/ml). Apomorphine will be infused subcutaneously for 14 days.

Treatment:

Drug: Apomorphine 0.25% (2.5mg/ml)