Treatment of Apomorphine-induced Skin Reactions: a Pilot Study

March 11, 2024 updated by: University Medical Center Groningen

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713GZ
        • Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: Massage with a spiky ball
Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
Active Comparator: Hydrocortisone cream 1%
Subjects are instructed to apply hydrocortisone cream 1% once daily for 14 days.
Drug: Hydrocortisone cream 1%
Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
Active Comparator: 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.
Drug: Subcutaneous hydrocortisone 10mg
Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
Other Names:
  • Solu-Cortef
Active Comparator: 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.
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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes on global perceived effect scale
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in histological skin tissue characteristics
Time Frame: 14 days
Histological skin tissue characteristics are presence of eosinophils, melanin-like pigment, fibrosis, lymphocytes and histiocytes.
14 days
Changes in nodule size (diameter)
Time Frame: 14 days
14 days
Changes in erythema size (diameter)
Time Frame: 14 days
14 days
Eosinophilia
Time Frame: 14 days
Defined as increased absolute eosinophil count
14 days
Personal or family history of atopic constellation
Time Frame: 14 days
Assessed with a questionnaire
14 days
Personal or family history of allergies
Time Frame: 14 days
Assessed with a questionnaire
14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver enzymes
Time Frame: 14 days
aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Teus Van Laar, MD PhD, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimated)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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