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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020908
Receipt No. R000022465
Scientific Title The follow-up of patients after the combination therapy with inactivated nevus and cultured epidermal autograft and the efficacy of the ruby laser irradiation to remove the residual melanin pigment
Date of disclosure of the study information 2016/02/08
Last modified on 2019/12/24

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Basic information
Public title The follow-up of patients after the combination therapy with inactivated nevus and cultured epidermal autograft and the efficacy of the ruby laser irradiation to remove the residual melanin pigment
Acronym The follow-up of patients after the combination therapy and the efficacy of the ruby laser irradiation
Scientific Title The follow-up of patients after the combination therapy with inactivated nevus and cultured epidermal autograft and the efficacy of the ruby laser irradiation to remove the residual melanin pigment
Scientific Title:Acronym The follow-up of patients after the combination therapy and the efficacy of the ruby laser irradiation
Region
Japan

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

Objectives
Narrative objectives1 The follow-up of patients after the combination therapy with inactivated nevus and 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 recurrence of nevus 1 year after the reconstruction
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The ruby laser irradiation
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 who received the combination therapy and have the take of inactivated nevus.
2.Written informed consent

Key exclusion criteria 1.Patients with no take of the inactivated nevus
2.Patients who have been judged not to be appropriate for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki MORIMOTO
Organization Kansai Medical University
Division name Department of Plastic and Reconstructive Surgery
Zip code
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
Middle name
Last name Miyuki Omura
Organization Kansai Medical University
Division name Center for Clinical Research
Zip code
Address 2-5-1 Shin-machi, Hirakata City, Osaka
TEL 072-804-0101
Homepage URL http://www5.kmu.ac.jp/prs/
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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(Kansai Medical University Hirakata Hospital)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 08 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 Completed
Date of protocol fixation
2016 Year 01 Month 31 Day
Date of IRB
2015 Year 12 Month 25 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2018 Year 01 Month 09 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 08 Month 31 Day
Date analysis concluded
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 06 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022465

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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