UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033409 |
|---|---|
| Receipt number | 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 | 2021/09/14 16:19:58 |
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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
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
jinsoo@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.prdoa.2021.100105
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 13 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037733
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| Registered date | File name |
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