UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of vocal fold scar with KP-100LI: phase I/II clinical trial
Title of the study (Brief title)	KP-100LI for vocal scar
Region	Japan

Condition
Condition	Vocal fold scar, sulcus
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore safty aspect and vocal outcome by local application of KP-100LI to vocal fold scar and sulcus
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safty aspect for KP-100LI
Key secondary outcomes	Therapeutic effect in VHI-10, Jitter, MPT, GRBAS, NMWA

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Transoral application of KP-100LI to the vocal fold
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnosis of vocal fold scar or suclus by stroboscopic exmaination No orgnic or neurologic disorder on the vocal fold More than 11 scor of VHI-10
Key exclusion criteria	Airway disease caused by burn History of malignant diseases Pregnant woman Severe systemic diseases
Target sample size	18

Research contact person
Name of lead principal investigator	Shigeru Hirano
Organization	Kyoto University Hospital
Division name	Otolaryngology
Address	Sakyo-ku, Kyoto 606-8507
TEL	075-751-3731
Email	hirano@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shigeru Hirano
Organization	Kyoto University Hospital
Division name	Otolaryngology
Address	Sakyo-ku, Kyoto 606-8507
TEL	075-751-3731
Homepage URL
Email	hirano@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Ministry of Health and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 03 Day
Anticipated trial start date	2014 Year 10 Month 03 Day
Last follow-up date	2016 Year 06 Month 16 Day
Date of closure to data entry	2016 Year 11 Month 04 Day
Date trial data considered complete	2016 Year 11 Month 04 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 10 Month 03 Day
Last modified on	2017 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017834