Conditions: Healthy
Keywords: SPM 962 rotigotine application site reaction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 120
Healthy volunteers: yes

Brief summary:
To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects

Detailed description:

Arms:
arm 1: Topical medication of steroid (Dexamethasone) to the application sites after the patch removal arm 2: Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal arm 3: No treatment to the application sites after the patch removal

Interventions: intervention 1: Topical steroid (Dexamethasone) intervention 2: Topical antihistamine (Diphenhydramine)
Intervention descriptions: intervention 1: for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal intervention 2: for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal

Protocol document: