A Trial to Explore Symptomatic Therapy for Application Si... | NCT01737931

NCT01737931

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical Steroid	Experimental	Topical medication of steroid (Dexamethasone) to the application sites after the patch removal	Drug: Topical steroid (Dexamethasone)
Topical antihistamine	Experimental	Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal	Drug: Topical antihistamine (Diphenhydramine)
No-treatment	No Intervention	No treatment to the application sites after the patch removal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topical steroid (Dexamethasone)	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin Irritation Score of the Application Site	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.	24 hours after 2 mg/24 hr patch removal
Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)	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).	24 hours after 2 mg/24 hr patch removal

Secondary Outcomes

Measure	Description	Time Frame
Skin Irritation Score 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.	Up to 72 hours after patch removal

Eligibility Module

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

Name	Affiliation	Role
Kyoji Imaoka, Mr	Otsuka Pharmaceutical Co., Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Kyeonggi-do			South Korea
Seoul National University Hospital

ID	Title	Description
FG000	Topical Steroid	Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
FG001	Topical Antihistamine	Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
FG002	No-treatment	No treatment to the application sites after the patch removal

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Topical Steroid	Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
BG001	Topical Antihistamine	Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Skin Irritation Score of the Application Site

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.

Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3

Posted

Mean

95% Confidence Interval

Scores on a scale

24 hours after 2 mg/24 hr patch removal

ID	Title	Description
OG000	Topical Steroid	Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
OG001	Topical Antihistamine

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Over-all	In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment. Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group.

ID	Term
D013256	Steroids
D003907	Dexamethasone
D006633	Histamine Antagonists
D004155	Diphenhydramine

ID	Term
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011246	Pregnadienetriols
D011245	Pregnadienes