UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022638 |
|---|---|
| Receipt number | 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 12:58:03 |
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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
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
m.tanaka@jp-ads.com
Sponsor or person
Institute
Zenyaku Kogyo Co., LTD,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026086
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| Registered date | File name |
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