UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Title of the study (Brief title)	A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of skin care products containing Bioceramide
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the safety of skin care products containing Bioceramide based upon 1) frequency, types and severity of adverse events, and 2) results of safety assessments by dermatologists
Key secondary outcomes	To evaluate the efficacy of skin care products containing Bioceramide based upon dermatological assessments, itch score, skin hydration and improvement grade of symptom

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	Other
Interventions/Control_1	Skin care products containing Bioceramide (cleanser, skin toner and moisturizing gel) are applied twice a day for 28 days
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	20 years-old <=
Age-upper limit	54 years-old >=
Gender	Male and Female
Key inclusion criteria	Atopic dermatitis patients; 1)with slight severity condition, 2)who are no need for treatment by steroidal and immunosuppressant drugs, 3)who are Japanese females and males between 20 years to 54 years old, and 4)who understand in detail and have written consent for the study protocol.
Key exclusion criteria	1)Patients with an evidence of skin inflammation caused by atopic dermatitis or with the other skin disease that would interfere with clinical evaluation 2)Patients with any known allergies and hypersensitivity to any of the ingredients of the test products 3)Patients with underlying disease who need a admission to a hospital 4)Patients taking steroidal or immunosuppressant drugs for atopic dermatitis 5)Patients with history of participation in another clinical study within six (6) months 6)Women who are pregnant or breastfeeding, and women of reproductive potential who are not willing to use adequate contraception during study 7)Patients who are not willing to observe the limitation or prohibit matters 8)Patients who are judged inappropriate to participate by investigators.
Target sample size	35

Research contact person
Name of lead principal investigator	Masatoshi Ito
Organization	Japan Aesthetic Dermatology Symposium
Division name	President
Address	15-1-604,Himonya 5-Chome,Meguro-ku,Tokyo,Japan
TEL	03-3794-1235
Email	m.tanaka@jp-ads.com

Public contact
Name of contact person	Mikiko Tanaka
Organization	Japan Aesthetic Dermatology Symposium
Division name	Secretariat
Address	2-3-5,Minatomirai,Nishi-ku,Yokohama-shi,Kanagawa,Japan
TEL	045-682-4114
Homepage URL
Email	m.tanaka@jp-ads.com

Sponsor
Institute	Zenyaku Kogyo Co., LTD,
Institute
Department

Funding Source
Organization	Zenyaku Kogyo Co., LTD,
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	クイーンズスクエア　皮膚科・アレルギー科 (Queen's Square Medical Facilities)

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 15 Day
Anticipated trial start date	2016 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2016 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026086