Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

Phase 2

Terminated

• Conditions: Apomorphine-induced Skin Reactions; Parkinson's Disease
• Interventions: Drug: Hydrocortisone cream 1%; Drug: Subcutaneous hydrocortisone 10mg; Drug: Apomorphine 0.25% (2.5mg/ml); Device: Massage with a spiky ball

• Registration Number: NCT02230930
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Start: 2015-06
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrocortisone cream 1%	Hydrocortisone cream 1%	Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.
Subcutaneous hydrocortisone 10mg	Subcutaneous hydrocortisone 10mg	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.
Apomorphine 0.25% (2.5mg/ml)	Apomorphine 0.25% (2.5mg/ml)	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.
Massage with a spiky ball	Massage with a spiky ball	Subjects are instructed to massage the apomorphine-induced skin reactions with a spiky ball 3 times a day for 2 minutes for 14 days.

Primary Outcome Measures

Name	Time	Method
Changes on global perceived effect scale	14 days

Secondary Outcome Measures

Name	Time	Method
Eosinophilia	14 days	Defined as increased absolute eosinophil count
Personal or family history of atopic constellation	14 days	Assessed with a questionnaire
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 allergies	14 days	Assessed with a questionnaire

Trial Locations

Locations (1)

Department of Neurology; 🇳🇱 Groningen, Netherlands