UMIN-CTR Clinical Trial

Public title

Pilot study to investigate the efficacy of rapamycin topical medicine against intractable hyperhidrosis

Acronym

Pilot study of the efficacy of rapamycin topical medicine against intractable hyperhidrosis

Scientific Title

Pilot study to investigate the efficacy of rapamycin topical medicine against intractable hyperhidrosis

Scientific Title:Acronym

Pilot study of the efficacy of rapamycin topical medicine against intractable hyperhidrosis

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 primary hyperhidrosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Skin findings at the site of topical application
Blood test results
Blood level of rapamycin
Serious adverse events
The measurement of the perspiration amount
photograph

Key secondary outcomes

Histological findings in biopsy specimens of the lesions
Improvement of subjective symptoms
Patient satisfaction
The measurement of the perspiration amount and area by Starch-Iodine Test

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The bilateral lesions are chosen as the treatment areas.
0.2% rapamycin gel is applied on the right lesion, and the gel base is applied on the left lesion twice a day for 6 weeks.

Interventions/Control_2

The bilateral lesions are chosen as the treatment areas.
0.2% rapamycin gel is applied on the left lesion, and the gel base is applied on the right lesion twice a day for 6 weeks.

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

15

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who are definitively diagnosed with primary hyperhidrosis according to the diagnostic criteria described by Japanese dermatological association.
2) Patients who couldn't receive effective treatments.
3) Patients who have bilateral symmetrical lesions.
4) Patients over 15 years of age.
5) Patients who can give written consent by themselves in understanding after having received enough explanation on this examination.
If the patients were under 20 years old, both written consent from the person with parental authority and written assent from the patient must be obtained.

Key exclusion criteria

1) Patients who cannot carry out this treatment plan.
2) Patients who have allergy to macrolide antibiotics.
3) Patients who received oral or topical administration of rapamycin or RAD001 within 12 months prior to the study entry.
4) Patients who received topical treatment of aluminum chloride or iontophoresis within one months prior to the study entry.
5) Patients who received local injection of Botox within three months prior to the study entry.
6) Patients who received sympathectomy within 12 months prior to the study entry.
7) Patients during pregnancy or lactation
8) Patients who cannot undergo QSART and starch-iodine test
9) Patients who were judged unsuitable for this study by the investigator.

Target sample size

3

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

2014

Year

12

Month

08

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

Open public recruiting

Date of protocol fixation

2014

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2014

Year

12

Month

09

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

08

Day

Last modified on

2014

Year

12

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018187