Treatment of Apomorphine-induced Skin Reactions: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT02230930|
Recruitment Status : Unknown
Verified May 2017 by Teus van Laar, University Medical Center Groningen.
Recruitment status was: Recruiting
First Posted : September 3, 2014
Last Update Posted : May 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Apomorphine-induced Skin Reactions||Drug: Apomorphine 0.25% (2.5mg/ml) Device: Massage with a spiky ball Drug: Hydrocortisone cream 1% Drug: Subcutaneous hydrocortisone 10mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin Reactions|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||November 2017|
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 Name: 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%).
- Changes on global perceived effect scale [ Time Frame: 14 days ]
- 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.
- Changes in nodule size (diameter) [ Time Frame: 14 days ]
- Changes in erythema size (diameter) [ Time Frame: 14 days ]
- Eosinophilia [ Time Frame: 14 days ]Defined as increased absolute eosinophil count
- Personal or family history of atopic constellation [ Time Frame: 14 days ]Assessed with a questionnaire
- Personal or family history of allergies [ Time Frame: 14 days ]Assessed with a questionnaire
- Liver enzymes [ Time Frame: 14 days ]aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AF), lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (gGT)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02230930
|Contact: Robbert WK Borgemeester, MD||+31 (0) email@example.com|
|Department of Neurology||Recruiting|
|Groningen, Netherlands, 9713GZ|
|Contact: Robbert Borgemeester, MD +31 (0) 50-3611519 firstname.lastname@example.org|
|Sub-Investigator: Robbert Borgemeester, MD|
|Principal Investigator: Teus van Laar, MD PhD|
|Principal Investigator:||Teus Van Laar, MD PhD||University Medical Center Groningen|