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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033409
Receipt No. R000037733
Scientific Title Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial.
Date of disclosure of the study information 2018/07/17
Last modified on 2019/07/26

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Basic information
Public title Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial.
Acronym SkinHeRo
Scientific Title Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial.
Scientific Title:Acronym SkinHeRo
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of heparinoid for preventing local skin reaction due to rotigotine transdermal patch.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes The difference in the 4-week change in Skindex 16 between the pretreatment group and the non-pretreatment group
Key secondary outcomes The difference in the 1-week and 8-week change in Skindex 16.
Skindex 16 score, DLQI score, UPDRS part3, PDQ-39, amount of heparinoid used, drop out rate (due to or not due to local skin reaction), dosage of rotigotine, at week 1, 4, and 8.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pretreatment by heparinoid
In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks.
Interventions/Control_2 Non-pretreatment by heparinoid.
The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. patients diagnosed as Parkinson's disease
2. patients without severe dementia
Key exclusion criteria 1. severe dementia
2. severe skin disease
3. severe allergic reactions to rotigotine or heparinoid
4. patients who are judged as not suitable for participation in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Jinsoo
Middle name
Last name Koh
Organization Wakayama Medical University
Division name Department of Neurology
Zip code 641-8510
Address 811-1, Kimiidera, Wakayama-city, Wakayama
TEL 073-441-0655
Email jinsoo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Jinsoo
Middle name
Last name Koh
Organization Wakayama Medical University
Division name Department of Neurology
Zip code 641-8510
Address 811-1, Kimiidera, Wakayama-city, Wakayama
TEL 073-441-0655
Homepage URL
Email jinsoo@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address 811-1, Kimiidera, Wakayama-city, Wakayama
Tel 073-447-2300
Email wa-rinri@wakayama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 和歌山県立医科大学付属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
2018 Year 07 Month 30 Day
Anticipated trial start date
2018 Year 07 Month 30 Day
Last follow-up date
2023 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 17 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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