UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016525 |
|---|---|
| Receipt number | 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 23:55:49 |
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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
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
mkaneda@derma.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Dermatology
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018217
