Objective: We examined to see whether to expand application sites of RTP other than the approved application sites.

Background: Rotigotine transdermal patch (RTP) is a dopamine agonist for the treatment of Parkinson’s disease (PD), which provides a slow and constant supply of the drug over the course of 24 hours. However, some people with PD cannot continue to use RTP due to application site reactionssuch as severe itching, redness, and swelling in the approved application sites (shoulder, upper arm, abdomen, flank, buttock, and thigh).

Method: 30 people with PD (12 men, mean age: 76 years of age) who use RTP with some application site reactions were enrolled in this study.When sticking RTP on the approved application sites (group 1)or on the shin (group 2)for 2 to 4 weeks, motor symptoms (MDS-UPDRS part 3 and Time Up and Go test: TUG),Clinical Global Impressions Scale (CGI), skin reactions (Visual Analog Scale: VAS), itching using (skin irritation score), and blood concentration of rotigotine were examined.

Results: The mean MDS-UPDRS part 3 in the group 2 (32.3±10.0) was significantly lower than that in the group 1 (34.8±11.3). There were no significant differences of the TUG steps and TUG time between thegroup 1 (21.2±13.8 steps/15.2±8.0 sec)and group 2 (20.9±10.1 steps/16.3±11.8 sec), respectively. CGI scale was much minimally or improved (37%), no change (50%), and minimally or much worse (13%). The mean VAS score in the group 2 (9.3±14.0 points)was significantly lower than that in the group 1 (41.3±19.7 points). The mean skin irritation score in the group 2 (0.30±0.28)was significantly lower than that in the group 1 (0.62±0.42). Blood rotigotine concentration of the group 2 (1.29±0.47 ng/ml)was significantly lower than that of the group 1 (1.41±0.54 ng/ml).

Conclusion: The results showed that MDS-UPDRS part 3was significantly improved in the shin group compared to the approved application sites group, whereas TUG test and CGI scale were not different between the two groups and blood rotigotine concentration was slightly reduced in the shin group. Application site reactions judged by VAS score and skin irritation score in the shin group were significantly improved compared to the approved application sites group. These results indicate that the shin can be a useful application site to paste RTP.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-study-for-expanding-application-sites-of-rotigotine-transdermal-patch/