NCT02230930

Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson's Disease
• Apomorphine-induced Skin Reactions

Interventions

Type	Name	Description
DRUG	Apomorphine 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%).
DEVICE	Massage with a spiky ball	Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
DRUG	Hydrocortisone cream 1%	Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
DRUG	Subcutaneous hydrocortisone 10mg	Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2014-09-03
• Last updated: 2024-03-13

Locations

1 site across 1 country: Netherlands