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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022638
Receipt No. R000026086
Scientific Title A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Date of disclosure of the study information 2016/06/08
Last modified on 2016/10/05

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Basic information
Public title A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Acronym A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Scientific Title A safety study of skin care products containing Bioceramide in atopic dermatitis patients
Scientific Title:Acronym 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
1st name
Middle name
Last name Masatoshi Ito
Organization Japan Aesthetic Dermatology Symposium
Division name President
Zip code
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
1st name
Middle name
Last name Mikiko Tanaka
Organization Japan Aesthetic Dermatology Symposium
Division name Secretariat
Zip code
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)

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 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

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
2016 Year 04 Month 15 Day
Date of IRB
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

Other
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

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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