A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
- Conditions
- Healthy
- Interventions
- Drug: Topical steroid (Dexamethasone)Drug: Topical antihistamine (Diphenhydramine)
- Registration Number
- NCT01737931
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical Steroid Topical steroid (Dexamethasone) Topical medication of steroid (Dexamethasone) to the application sites after the patch removal Topical antihistamine Topical antihistamine (Diphenhydramine) Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
- Primary Outcome Measures
Name Time Method Skin Irritation Score of the Application Site 24 hours after 2 mg/24 hr patch removal Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.
The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.Itching of Application Site Evaluated by the Visual Analogue Scale (VAS) 24 hours after 2 mg/24 hr patch removal Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.
The score ranges from 0 (no itching) to 100 (strongest imaginable itching).
- Secondary Outcome Measures
Name Time Method Skin Irritation Score After Patch Removal Up to 72 hours after patch removal Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.
Itching of Application Site Evaluated by VAS After Patch Removal Up to 96 hours after patch removal Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).
The score ranges from 0 (no itching) to 100 (strongest imaginable itching).
Trial Locations
- Locations (2)
Seoul National University Bundang Hospital
🇰🇷Kyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of