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Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

NCT02230930 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-03-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Teus Van Laar, MD PhD · University Medical Center Groningen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230930 on ClinicalTrials.gov