UMIN-CTR Clinical Trial

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
Last 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
1st 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