Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial.

Phase 1

• Conditions: Parkinson' s disease

• Registration Number: JPRN-UMIN000033409
• Lead Sponsor: Wakayama Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Study Completion: 2021-03-31
• Results First Posted: 2021-08-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1. severe dementia 2. severe skin disease 3. severe allergic reactions to rotigotine or heparinoid 4. patients who are judged as not suitable for participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the 4-week change in Skindex 16 between the pretreatment group and the non-pretreatment group

Secondary Outcome Measures

Name	Time	Method
The difference in the 1-week and 8-week change in Skindex 16. Skindex 16 score, DLQI score, UPDRS part3, PDQ-39, amount of heparinoid used, drop out rate (due to or not due to local skin reaction), dosage of rotigotine, at week 1, 4, and 8.