UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020647
Receipt number R000023830
Scientific Title A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)
Date of disclosure of the study information 2016/01/25
Last modified on 2017/05/02 14:49:42

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Basic information

Public title

A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)

Acronym

A clinical trial to evaluate the efficacy and safety of OSD-001 (a gel formulation containing sirolimus)
in patients with primary palmar hyperhidrosis

Scientific Title

A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)

Scientific Title:Acronym

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

1st name
Middle name
Last name Mari Kaneda

Organization

Osaka University Hospital

Division name

Department of Dermatology

Zip code


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

1st name
Middle name
Last name Mari Kaneda

Organization

Osaka University Hospital

Division name

Department of Dermatology

Zip code


Address

2-15, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-5111

Homepage URL


Email

mkaneda@derma.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Hospital

Institute

Department

Personal name



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)



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

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


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

2015 Year 12 Month 09 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023830


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name