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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030265
Receipt No. R000034565
Scientific Title A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Date of disclosure of the study information 2017/12/05
Last modified on 2019/03/25

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Basic information
Public title A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Acronym A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Scientific Title A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Scientific Title:Acronym A single arm, open-label study evaluating the safety and efficacy of ra148 in patients with atopic dermatitis.
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the clinical efficacy and safety of topical cream (ra148) in the treatment of atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of usefulness of long-term (12mo) application of ra148 on atopic disease by the principal doctor.
Key secondary outcomes 1) Severity classification (simple method) of atopic dermatitis developed by the advisory committee of atopic dermatitis severity classification of Japanese Dermatological Association at the test site.
2) Evaluation of the digital images of the test site.
3) Questionnaires for QOL assessment in atopic dermatitis.
4) Evaluation of the patient's diaries (Medication compliance, Subjective symptoms, The degree of itchiness, etc.).

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 Apply topical moisturizing ingredient containing cream (ra148) twice a day for 12 months.
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
16 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with atopic dermatitis who has mild or moderate rash and visits MIE HIFUKA CLINIC.
2) Those who can acquire written consent based on the voluntary intention before starting the study (For minors under the age of 20, in addition to their consent, the consent of the guardian in writing shall also be obtained).
Priority is given to those who normally use Hirudoid (Maruho Co., Ltd.) formulation as a humectant.
Key exclusion criteria 1) Patients with severe skin disorders on test site (both arms) and deemed inappropriate to participate in this study by the doctor.
2) Patients who have a history of hypersensitivity to heparin analog preparation.
3) Pregnant or lactating patients. Patients with suspicion of pregnancy.
4) Patients deemed inappropriate to participate in this study by the principal doctor or investigators.
5) Patients with hemorrhagic blood disease; e.g. Hemophilia, Thrombocytopenia, Purpura, etc.
6) Patients who are expected to promote serious consequences with minimal bleeding.
7) Patients who have undergone climacteric disorder or postmenopausal "hormone replacement therapy"
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Isoda, M.D., Ph.D.
Organization MIE HIFUKA CLINIC
Division name Chief of Clinic
Zip code
Address 633-61 Takano-o-cho Tsu-shi Mie, 514-2221, JAPAN
TEL 059-230-8787
Email isoda@miehifu.jp

Public contact
Name of contact person
1st name
Middle name
Last name Azumi Nagasawa, Ph.D.
Organization Kao Corporation
Division name R&D - Core Technology -
Zip code
Address 2606 Akabane Ichikai-machi Haga-gun Tochigi 321-3497, JAPAN
TEL 0285-68-7706
Homepage URL
Email nagasawa.azumi@kao.com

Sponsor
Institute MIE HIFUKA CLINIC
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 みえひふ科クリニック(三重県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 05 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 Completed
Date of protocol fixation
2017 Year 10 Month 17 Day
Date of IRB
2017 Year 10 Month 17 Day
Anticipated trial start date
2017 Year 12 Month 18 Day
Last follow-up date
2019 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034565

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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