UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)
Title of the study (Brief title)	A clinical trial to evaluate the efficacy and safety of OSD-001 (a gel formulation containing sirolimus) in patients with primary palmar hyperhidrosis
Region	Japan

Condition
Condition	Primary palmar hyperhidrosis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of OSD-001 (a gel formulation containing 0.2% or 0.4% of sirolimus) in patients with primary palmar hyperhidrosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Improvement ratio of palmar sweating after 8 weeks treatment
Key secondary outcomes	1) Improvement ratio of palmar sweating after 4 weeks treatment 2) Improvement ratio of HDSS score after 4 weeks or 8weeks treatment 3)improvement ratio of DLQI or CDLQI score after 4 weeks or 8 weeks treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	0.2% sirolimus gel 8weeks
Interventions/Control_2	0.4% sirolimus gel 8 weeks
Interventions/Control_3	Placebo 8weeks
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	12 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects who diagnosed as primary hyperhidrosis according to the guideline of Japan Dermatology Association. 2) Subjects who have HDSS score 3 or 4 and have troubles in daily life. 3) Subjects who have 1.0mg/cm2/min or more of sweat amount.
Key exclusion criteria	1)Subjects who received a surgical treatment including the sympathetic nerve interception within 12 months prior to the study-entry . 2)Subjects who received a treatment with Sirolimus, Everolimus or Temsirolimus within 6 months prior to the study-entry. 3) Subjects who received a treatment with botulinum toxin within 12 months prior to the study-entry . 4) Subjects who received a treatment with aluminum chloride solution or iontophoresis within a month prior to the study-entry . 5) Subjects who received a treatment with anticholinergic drug or antihistamine drug within two weeks prior to the study-entry .
Target sample size	45

Research contact person
Name of lead principal investigator	Mari Kaneda
Organization	Osaka University Hospital
Division name	Department of Dermatology
Address	2-15, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-5111
Email	mkaneda@derma.med.osaka-u.ac.jp

Public contact
Name of contact person	Mari Kaneda
Organization	Osaka University Hospital
Division name	Department of Dermatology
Address	2-15, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-5111
Homepage URL
Email	mkaneda@derma.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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	大阪大学医学部附属病院（大阪府）、東京医科歯科大学医学部付属病院（東京都）、愛知医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 09 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date	2016 Year 12 Month 20 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete	2017 Year 02 Month 28 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	2016 Year 01 Month 20 Day
Last modified on	2017 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023830