A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Otsuka

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Topical steroid (Dexamethasone); Drug: Topical antihistamine (Diphenhydramine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01737931

243-12-002

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Topical Steroid

Experimental group

Description:

Topical medication of steroid (Dexamethasone) to the application sites after the patch removal

Treatment:

Drug: Topical steroid (Dexamethasone)

Topical antihistamine

Experimental group

Description:

Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal

Treatment:

Drug: Topical antihistamine (Diphenhydramine)

No-treatment

No Intervention group

Description:

No treatment to the application sites after the patch removal