UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of a microwave device for treating axillary hyperhidrosis: Prospective, randomized, and split-face comparative study
Title of the study (Brief title)	The efficacy of a microwave device for treating axillary hyperhidrosis
Region	Japan

Condition
Condition	axillary hyperhidrosis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is conducted to evaluate the efficacy of microwave-based devices for axillary hyperhidrosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Procedure efficacy, patient satisfaction, and treatment safety are assessed for 12 months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
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 patients with axillary hyperhidrosis treated one sesseion with the microwave-based device.
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	The patients with axillary hyperhidrosis
Key exclusion criteria	Patients who were pregnant or lactating, who had concomitant treatment to involved skin areas or had a propensity for keloid.
Target sample size	30

Research contact person
Name of lead principal investigator	Chikako Kaminaka
Organization	Wakayama Medical University
Division name	Department of Dermatology
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0661
Email	kamikami@wakayama-med.ac.jp

Public contact
Name of contact person	Chikako Kaminaka
Organization	Wakayama Medical University
Division name	Department of Dermatology
Address	811-1 Kimiidera, Wakayama, Japan
TEL	073-441-0661
Homepage URL
Email	kamikami@wakayama-med.ac.jp

Sponsor
Institute	Department of Dermatology, Wakayama Medical University
Institute
Department

Funding Source
Organization	JMEC Co., LTD (Tokyo, Japan)
Organization
Division
Category of Funding Organization	Other
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	2016 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 08 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026600