UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory clinical trial for the congenital melanocytic nevi using the combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Acronym	The combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Scientific Title	An exploratory clinical trial for the congenital melanocytic nevi using the combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Scientific Title:Acronym	The combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Region	Japan

Condition
Condition	Congenital melanocytic nevi
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploration of the take of the pressurized nevus in comnination with the cultured epidermal autograft
Basic objectives2	Others
Basic objectives -Others	The operability assessment of high hydrostatic pressurization of nevus tissue
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	The epithelialization grafted site at 12 weeks after the implantation
Key secondary outcomes	The operability assessment of high hydrostatic pressurization of nevus tissue

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Apply cultured epidermal autografts and the pressirized nevus on the wound after the removal of the nevus
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with congenital pigmented nevus that can not be excised using the existing treatment 2.The hairy nevus or the nevus with nevus cells in its reticular layer 3.Operable patients 4.Written informed consent
Key exclusion criteria	1.Patients with scar tissue that prevent the take of inactivated nevus 2.The nevus that has been treated by cultured epidermal autografts in previous clinical trials
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Morimoto
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	5731010
Address	2-5-1 Shin-machi, Hirakata City, Osaka
TEL	072-804-0101
Email	morimotn@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Naoki Middle name Last name Morimoto
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
Zip code	5731010
Address	2-5-1 Shin-machi, Hirakata City, Osaka
TEL	072-804-0101
Homepage URL	http://kmu-prs.adiva.jp/
Email	morimotn@hirakata.kmu.ac.jp

Sponsor
Institute	Department of Plastic and Reconstructive Surgery, Kansai Medical University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	kansai Medical University IRB
Address	2-5-1,Shinmachi,Hirakata City, Osaka
Tel	072-804-2440
Email	rinriirb@hirakata.kmu.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	関西医科大学附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 15 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	3
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	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 02 Month 15 Day
Last follow-up date	2020 Year 02 Month 29 Day
Date of closure to data entry	2020 Year 02 Month 29 Day
Date trial data considered complete	2020 Year 10 Month 31 Day
Date analysis concluded	2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 01 Month 11 Day
Last modified on	2020 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035136