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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008315
Receipt No. R000009299
Scientific Title Clinical trial for development of topical rapamycin treatment for rosacea
Date of disclosure of the study information 2012/07/02
Last modified on 2013/09/12

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Basic information
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
Condition rosacea
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

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)

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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 02 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 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
Other related information

Management information
Registered date
2012 Year 07 Month 02 Day
Last modified on
2013 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009299

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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