HealthyPhase 1NCT01737931

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

A Phase 1 study testing Topical steroid (Dexamethasone) and Topical antihistamine (Diphenhydramine) in people with Healthy, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Topical steroid (Dexamethasone) and Topical antihistamine (Diphenhydramine)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesSouth Korea
Study dates: Aug 2012to Nov 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Show all 16Show fewer

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 locations and contacts

2 sites in 1 country.

South Korea2 sites

Seoul National University Bundang Hospital
Kyeonggi-do
Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: An Open-Label 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

Conditions: Healthy
Being tested: Topical steroid (Dexamethasone), Topical antihistamine (Diphenhydramine)
Keywords: SPM 962, rotigotine, application site reaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01737931
Study group	Role	What they receive
Topical Steroid	Experimental	Topical medication of steroid (Dexamethasone) to the application sites after the patch removal Receives: Drug: Topical steroid (Dexamethasone)
Topical antihistamine	Experimental	Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal Receives: Drug: Topical antihistamine (Diphenhydramine)
No-treatment	No intervention	No treatment to the application sites after the patch removal

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 24 hours after 2 mg/24 hr patch removal

Secondary outcomes (2)

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.
Measured: Up to 72 hours after patch removal
Itching of Application Site Evaluated by VAS 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).
Measured: Up to 96 hours after patch removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Nov 2012

First posted30 Nov 2012 (estimated)
Study startAug 2012
Primary completionOct 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01737931
Sponsor's protocol ID: 243-12-002
Status last verified: Mar 2014
First submitted: 25 Nov 2012
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject
ClinicalTrials.gov ID: NCT01737931
Acronym / sponsor ID: 243-12-002
Conditions: Healthy
Keywords: SPM 962, rotigotine, application site reaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Oct 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 30 Nov 2012 (estimated)
Results: Posted 29 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Topical Steroid	Experimental	Drug: Topical steroid (Dexamethasone)Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
Topical antihistamine	Experimental	Drug: Topical antihistamine (Diphenhydramine)Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
No-treatment	No intervention	–No treatment to the application sites after the patch removal

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Topical steroid (Dexamethasone)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	Drug	Topical Steroid
Topical antihistamine (Diphenhydramine)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	Drug	Topical antihistamine

Primary outcome

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.
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).

2 secondary outcomes

Skin Irritation Score After Patch Removal
Time frame: Up to 72 hours after patch removal
Itching of Application Site Evaluated by VAS After Patch Removal
Time frame: Up to 96 hours after patch removal

Results and safety

Results posted to the registry on 29 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Topical Steroid	38	38
Topical Antihistamine	40	38
No-treatment	39	38

Primary outcome: Skin Irritation Score of the Application Site

Time frame: 24 hours after 2 mg/24 hr patch removal. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Topical Steroid n = 19	Topical Antihistamine n = 19	No-treatment n = 20
Value	0.237 (0.084 to 0.390)	0.289 (0.136 to 0.422)	0.250 (0.101 to 0.399)

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

Primary outcome: Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)

Time frame: 24 hours after 2 mg/24 hr patch removal. Mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Topical Steroid n = 37	Topical Antihistamine n = 38	No-treatment n = 38
Value	1.6 (0.5 to 2.7)	0.4 (-0.7 to 1.6)	0.9 (-0.2 to 2.0)

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Over-all	0 of 120 (0%)	41 of 120 (34.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kyoji Imaoka, Mr study director

Otsuka Pharmaceutical Co., Ltd.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Topical steroid (Dexamethasone) and Topical antihistamine (Diphenhydramine) in people with Healthy, run by Otsuka Pharmaceutical Co., Ltd. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Irritation Score of the Application Site (time frame: 24 hours after 2 mg/24 hr patch removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01737931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.