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
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
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
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
