UMIN-CTR Clinical Trial

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

hyperhidrosis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Dermatology
Graduate School of Medicine, Osaka University

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大阪府）

Date of disclosure of the study information

2015

Year

02

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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