Preventive effect of a heparinoid-containing product on the application site reaction of the rotigotine transdermal patch in Parkinson's disease: A pilot randomized clinical trial (the SkinHeRo study)

Abstract

Introduction: The rotigotine transdermal patch (RTP) is a dopamine agonist used to treat Parkinson's disease (PD) but is sometimes discontinued because of application site reactions (ASRs). We aimed to investigate the effect of a heparinoid-containing product (HCP) for preventing ASRs due to the RTP by conducting a randomized controlled pilot trial.

Methods: Twenty patients with idiopathic non-demented PD were randomized to the skin care group using a HCP (group H) and the non-skin care group (group N). The primary outcome was the change in the baseline Skindex-16 score (ΔSkindex-16) at week 4. In addition, skin symptoms were also evaluated using the Dermatology Life Quality Index (DLQI) and International Contact Dermatitis Research Group (ICDRG) system for clinical scoring allergic patch test reactions up to week 8.

Results: The ΔSkindex-16 score at week 4 tended to be lower in group H than in group N, although the difference was not statistically significant (-1.5 ± 2.0 vs 1.3 ± 10.9, p = 0.53). When the patients with baseline Skindex-16 scores ≥ 7 were excluded, the ΔSkindex-16 at week 4 was significantly lower in group H (-1.5 ± 2.0 vs 6.1 ± 8.6, p = 0.042). The DLQI also tended to be lower in group H at weeks 4 and 8, but not significantly (p = 0.066 and p = 0.077, respectively). The ICDRG score at week 4 was significantly lower in group H (p = 0.044).

Conclusion: We suggest that the HCP has a preventive effect against ASRs cause by the RTP.

Keywords: AE, adverse event; Moisturizing; Parkinson’s disease; Patch; Quality of life, dopamine agonist; Skin.