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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016525
Receipt No. R000018217
Scientific Title Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers
Date of disclosure of the study information 2015/02/12
Last modified on 2015/02/12

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Basic information
Public title Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers
Acronym Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers
Scientific Title Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers
Scientific Title:Acronym Phase 1 study to examine the safety and dose-dependent effect of rapamycin topical medicine on perspiration in healthy volunteers
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to explore the safety and the effectiveness of rapamycin topical medication for sweating in healthy volunteers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Skin findings at the site of topical application
Subjective findings at the site of topical application
Serious adverse events
Amount of sweating
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The bilateral lesions are chosen as the treatment areas.
Rapamycin gel is applied on the left lesion, and the gel base is applied on the right lesion.
Amount of sweating is measured before application, 30 minutes after application, and 60 minutes after application.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy volunteers over 20 years of age.
2) Healthy volunteers who can give written consent by themselves in understanding after having received enough explanation on this examination.
Key exclusion criteria 1) A person who cannot carry out this treatment plan.
2) A person who have allergy to macrolide antibiotics.
3) A person who received oral administration of rapamycin or RAD001 within 12 months prior to the study entry.
4) A person who received topical administration of rapamycin or RAD001 within three days prior to the study entry.
5) A person who received topical treatment of aluminum chloride or iontophoresis within one months prior to the study entry.
6) A person who received local injection of Botox within three months prior to the study entry.
7) A person who received sympathectomy within 12 months prior to the study entry.
8) A person during pregnancy or lactation
9) A person who cannot undergo QSART and starch-iodine test
10) A person who were judged unsuitable for this study by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mari Wataya-Kaneda
Organization Graduate School of Medicine, Osaka University
Division name Department of Dermatology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL 06-6879-3031
Email mkaneda@derma.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Wataya-Kaneda
Organization Graduate School of Medicine, Osaka University
Division name Department of Dermatology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL 06-6879-3031
Homepage URL
Email mkaneda@derma.med.osaka-u.ac.jp

Sponsor
Institute Department of Dermatology
Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology of Japan

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)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 12 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 12 Day
Last modified on
2015 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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