UMIN-CTR Clinical Trial

Public title

Clinical trial for development of topical rapamycin treatment for rosacea

Acronym

Clinical trial for development of topical rapamycin treatment for rosacea

Scientific Title

Clinical trial for development of topical rapamycin treatment for rosacea

Scientific Title:Acronym

Clinical trial for development of topical rapamycin treatment for rosacea

Region

Japan

Condition

rosacea

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this trial is to develop an effective and safe treatment for rosacea.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III

Primary outcomes

Changes in redness and size of eruptions after 4 and 8 weeks of treatment, and at 4 and 8 weeks after end of treatment

Key secondary outcomes

Appearance of contact dermatitis
Rapamycin levels in whole blood
histological findings in specimens of skin tissue in the cases who agree with skin biopsy

Study type

Interventional

Basic design

Cross-over

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

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The similar eruptions of rosacea on both sides of the face are chosen as the treatment lesions.
0.2% rapamycin ointment is applied on the skin lesion on the right, and the ointment base or the ointment base with lactose is applied on the similar skin lesion on the left twice a day for 8 weeks.

Interventions/Control_2

The similar eruptions of rosacea on both sides of the face are chosen as the treatment lesions.
0.2% rapamycin ointment is applied on the skin lesion on the left, and the ointment base or the ointment base with lactose is applied on the similar skin lesion on the right twice a day for 8 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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with rosacea who come to our outpatient department.
2) Patients who are resistant to previous treatment.
3) Patients who want to receive the treatment with the rapamycin ointment.
4) Patients who have not received topical steroid treatment for more than 2 months in the previous year.

Key exclusion criteria

1) Patients who cannot comply with the treatment plan.
2) Patients who are allergic to macrolide antibiotics.
3) Patients who received oral administration of rapamycin or RAD001 within six months prior to the study entry.
4) Patients who received oral administration of macrolide antibiotics for more than 7 days within three months prior to the study entry.
5) Patients who received topical steroid treatment within three months prior to the study entry.
6) Patients who received topical treatment of tacrolimus, nadifloxacin, clindamycin or adapalene within a month prior to the study entry.
7) Patients who have a large wound or scar on the face, which would interfere the treatment or the assessment.
8) Patients who are pregnant or lactating.
9) Patients under 18 years of age.
10) Patients who were judged unsuitable for this study by the investigator.

Target sample size

5

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)

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

Date of disclosure of the study information

2012

Year

07

Month

02

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

2012

Year

04

Month

03

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

Day

Last follow-up date

2015

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

07

Month

02

Day

Last modified on

2013

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009299