A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
Condition: Healthy
Intervention: Topical steroid (Dexamethasone); Topical antihistamine (Diphenhydramine)
Intervention description: 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; 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
Intervention MeSH terms: Diphenhydramine; Promethazine; Dexamethasone; Histamine H1 Antagonists; Histamine Antagonists
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: SPM 962; rotigotine; application site reaction

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is a male or female and aged between 20 and 45 years of age (inclusive)

          -  Subject is of normal body weight as determined by a body-mass index (BMI) between 18
             and 28 kg/m2

          -  Subject is healthy as determined by EA (medical history, physical examination, skin
             evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)

          -  Subject is surgically sterile; subject has been postmenopausal for at least 12
             consecutive months if female; or subject agrees to remain abstinent or to follow two
             acceptable methods of birth control from EA to the end of observation period. (fore
             male and female subjects)

        Exclusion Criteria:

          -  Subject has a history or complication of epilepsy and/or seizures

          -  Subject has clinically relevant changes in the ECG, such as second- or third-degree AV
             block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or
             of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA

          -  Subject has a clinically relevant hepatic dysfunction

          -  Subject has a clinically relevant renal dysfunction

          -  Subject has a history of significant skin hypersensitivity to adhesives or other
             transdermal products or recent unresolved contact dermatitis

          -  Subject has a history or complication of atopic or eczematous dermatitis, psoriasis,
             and/or an active skin disease or skin tumors

          -  Subject has more than 1 known or suspected drug hypersensitivity, in particular to any
             component of the trial medication

          -  Subject has a history of chronic alcohol or drug abuse within the last 5 years

          -  Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab

          -  Subject tests positive for alcohol and/or drugs at EA

          -  Subject is taking any prohibited concomitant medication

          -  Subject has a history or complication of narrow angle glaucoma

          -  Subject has a history or complication of respiratory or cardiovascular disorders
             (e.g., heart failure, coronary heart disease, hypertension, arrhythmia,
             tachyarrhythmia, or myocardial infarction)

          -  Subject has a history or complication of psychic abnormality, psychiatric or
             neurologic illness, or autonomic neuropathy

          -  Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction,
             especially hyperthyroidism or other endocrine disorders

          -  Subject has a history or complication of malignancy