UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030265 |
|---|---|
| Receipt number | 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 15:30:33 |
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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
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
nagasawa.azumi@kao.com
Sponsor or person
Institute
MIE HIFUKA CLINIC
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034565
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