UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037733