UMIN-CTR Clinical Trial

Basic information
Public title	Verification test of Moisturizing effect for patients with atopic dermatitis.
Acronym	Verification test of Moisturizing effect.
Scientific Title	Placebo-controlled, double-blind, randomized controlled trials that verify moisturizing effect of patients with atopic dermatitis by lotion containing plant extract.
Scientific Title:Acronym	Placebo-controlled, double-blind, randomized controlled trials that verify moisturizing effect.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of continuous application for 12-weeks of the moisturizing lotion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stratum corneum water content
Key secondary outcomes	Skin observation by doctor Transepidermal water loss Microscope photography Collecting stratum corneum

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Continuous application for 12-weeks two types of the moisturizing lotion (Placebo on the left, Lotion containing plant extract on the right).
Interventions/Control_2	Continuous application for 12-weeks two types of the moisturizing lotion (Placebo on the right, Lotion containing plant extract on the left).
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	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Individuals with mild atopic dermatitis. 2)Individuals with dryness on the inside of the left and right forearms. 3)Individuals who agree to participate in this test after understanding the explanation of exam and show willingness to participate in the exam.
Key exclusion criteria	1)Individuals with moderate or higher atopic dermatitis. 2)Individuals who are taking orally steroids, antihistamine, anti-allergic agent, immunosuppressant, tranquilizers. 3)Individuals who have serious allergy by the use of topical drugs, cosmetics, quasi drugs and others in the past. 4)Individuals considered to be inappropriate for inclusion to have a serious illness. 5)Individuals who are being treated or hospitalized due to illness (Excluding colds and dentistry). 6)Individuals who have a family that are working at Pharmaceutical company or cosmetic company. 7)Individuals who are currently participating on survey using foods, cosmetics and quasi drugs, or are participating on any other clinical study, or have done so in the previous four weeks. 8)Individuals who are regarded to be inappropriate for this study by doctors.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kayoko Middle name Last name Numano
Organization	Numano Clinic
Division name	Dermatologist
Zip code	370-0815
Address	15, Yanagawachou, Takasaki-shi, Gunma, Japan
TEL	027-322-2926
Email	kaco121@yahoo.co.jp

Public contact
Name of contact person	1st name Takanori Middle name Last name Inai
Organization	FUJI-SANGYO CO.,LTD
Division name	Research and Development Laboratory
Zip code	763-0071
Address	1301, Tamurachou, Marugame-shi, Kagawa, Japan
TEL	0877-25-3221
Homepage URL
Email	inai@fuji-sangyo.co.jp

Sponsor
Institute	FUJI-SANGYO CO.,LTD
Institute
Department

Funding Source
Organization	FUJI-SANGYO CO.,LTD
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	General Incorporated Association Crinical Research Review Center
Address	2972-8-603 Ishikawamachi Hachioji-shi,Tokyo,192-0032,JAPAN
Tel	090-3547-6398
Email	crrctakashima@kpd.biglobe.ne.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 18 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	25
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	2020 Year 09 Month 09 Day
Date of IRB	2020 Year 09 Month 09 Day
Anticipated trial start date	2020 Year 09 Month 18 Day
Last follow-up date	2020 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 17 Day
Last modified on	2022 Year 09 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047752