UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory clinical trial for the congenital melanocytic nevi using the noble combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Title of the study (Brief title)	The noble combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Region	Japan

Condition
Condition	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	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	The take of inactivated nevus with cultured epidermal autograft at 8weeks after implantation
Key secondary outcomes	Adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Apply cultured epidermal autografts on the pressirized nevusApply 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	7 months-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with congenital pigmented nevus that can not be excised and sutured primarily 2.The area of the nevus is more than 0.25% of the body surface area 3.Operable patients more than 7 months old and 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 already. 3.A history of malignant tumor with disease free interval of 5 years or less 4.Other patients judged by the investigator or sub-investigator to be inappropriate as a subject of this study. 5.Patients who have received this protocol treatments twice.
Target sample size	10

Research contact person
Name of lead principal investigator	Naoki Morimoto
Organization	Kansai Medical University
Division name	Department of Plastic and Reconstructive Surgery
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	Omura Miyuki
Organization	Kansai Medical University
Division name	Center for Clinical Research
Address	2-5-1 Shin-machi, Hirakata City, Osaka
TEL	072-804-0101
Homepage URL	http://www5.kmu.ac.jp/prs/index.html
Email	kmuccr@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
Nationality of Funding Organization	Japan

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

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	関西医科大学附属枚方病院

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 22 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2018 Year 08 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 04 Month 30 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 25 Day
Last modified on	2019 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022198