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Completed

NCT Number: NCT01737931

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Kyeonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Topical antihistamine (Diphenhydramine)

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 antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal

Primary outcomes

  1. Skin Irritation Score of the Application Site

    Time frame: 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.

  2. Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)

    Time frame: 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 outcomes

  1. Skin Irritation Score After Patch Removal

    Time frame: 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.

  2. Itching of Application Site Evaluated by VAS After Patch Removal

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 30, 2012
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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