UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006923 |
|---|---|
| Receipt number | R000008179 |
| Scientific Title | A Multicenter,Randomized,Double Blind,Placebo Controlled,Parallel Group Trial to Evaluate The Effect of Edible Hyaluronic Acid of Cockscomb Origin on Atopic Dermatitis Patiennt. |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2013/10/03 14:24:36 |
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Basic information
Public title
A Multicenter,Randomized,Double Blind,Placebo Controlled,Parallel Group
Trial to Evaluate The Effect of Edible
Hyaluronic Acid of Cockscomb Origin on
Atopic Dermatitis Patiennt.
Acronym
A Multicenter,Randomized,Double Blind,Placebo Controlled,Parallel Group
Trial to Evaluate The Effect of Edible
Hyaluronic Acid of Cockscomb Origin on
Atopic Dermatitis Patiennt.
Scientific Title
A Multicenter,Randomized,Double Blind,Placebo Controlled,Parallel Group
Trial to Evaluate The Effect of Edible
Hyaluronic Acid of Cockscomb Origin on
Atopic Dermatitis Patiennt.
Scientific Title:Acronym
A Multicenter,Randomized,Double Blind,Placebo Controlled,Parallel Group
Trial to Evaluate The Effect of Edible
Hyaluronic Acid of Cockscomb Origin on
Atopic Dermatitis Patiennt.
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the Effect of Edible Hyaluronic Acid of Cockscomb Origin on Atopic Dermatitis Patient with a randomized, double-blind, multi-center, placebo-controlled study
The validity is verified with "The improvement evaluation of atopic dermatitis severity ", and "The improvement evaluation according to the judgment of the degree of itchy" in pre-intake of test food, under intake and post-intake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The improvement evaluation of atopic dermatitis severity
The improvement evaluation according to the judgment of the degree of itchy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The test group consists of four groups containing a placebo.
Dosage is set up by age.
*4 to 12 years 900mg/day
*13 to 44 years 1200mg/day
*ECME 900mg/day
*ECME 1200mg/day
*Placebo 900mg/day
*Placebo 1200mg/day
The intake status of the test food and
the degree of itching are confirmed by
a patient diary.
Interventions/Control_2
The test group consists of four groups containing a placebo.
Dosage is set up by age.
*4 to 12 years 900mg/day
*13 to 44 years 1200mg/day
*ECME 900mg/day
*ECME 1200mg/day
*Placebo 900mg/day
*Placebo 1200mg/day
The intake status of the test food and
the degree of itching are confirmed by
a patient diary.
Interventions/Control_3
The test group consists of four groups containing a placebo.
Dosage is set up by age.
*4 to 12 years 900mg/day
*13 to 44 years 1200mg/day
*ECME 900mg/day
*ECME 1200mg/day
*Placebo 900mg/day
*Placebo 1200mg/day
The intake status of the test food and
the degree of itching are confirmed by
a patient diary.
Interventions/Control_4
The test group consists of four groups containing a placebo.
Dosage is set up by age.
*4 to 12 years 900mg/day
*13 to 44 years 1200mg/day
*ECME 900mg/day
*ECME 1200mg/day
*Placebo 900mg/day
*Placebo 1200mg/day
The intake status of the test food and
the degree of itching are confirmed by
a patient diary.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 4 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Age: a patient who is 4 to 44 years old at the time of Informed Consent
*Sex: don't ask
*hospitalization and visitors
*Disease: The patient who is diagnosed with atopic dermatitis based on the Japanese Dermatological Association atopic dermatitis clinical practice guideline and who wishes to treat or under medical treatment.
Key exclusion criteria
1)
- Contact dermatitis
- Seborrheic dermatitis
- Prurigo simplex
- scabies
- Heat rash
- Fishskin disease
- Leather fat deficiency eczema
- Hand eczema (in order to except hand eczema other than atopic dermatitis), and a cutaneous lymphoma
- Psoriasis
- The disease by immunity deficiency
- Collagen disease (SLE,Dermatomyositis)
- Nether ton syndrome
2) Patient which have allergies in chicken
3)Mucopolysaccharidosis
4) The woman and nursing mother who wish to become pregnant during pregnancy or exam time
5)Those who have been suffered from critical liver and renal damage, and cardiac disease
6)The patient who has critical complications
7)Those who participated in other clinical tests within the past three months
8)The patient considered to be disqualified by judgment of the doctor who examines
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigehiro Kure |
Organization
Sanbongi Clinic
Division name
Clinic Director
Zip code
Address
2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 4710101, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Urakawa |
Organization
ADAPTGEN PHARMACEUTICAL CO.LTD.
Division name
Clinical development Section
Zip code
Address
1-90-1, Kamiyama-cho, Tajimi-shi, Gifu, 5070022, Japan
TEL
0572-56-1111
Homepage URL
http://www.adaptgen.co.jp/
adurakawa@adaptgen.co.jp
Sponsor or person
Institute
ADAPTGEN PHARMACEUTICAL CO.LTD.
Institute
Department
Personal name
Funding Source
Organization
ADAPTGEN PHARMACEUTICAL 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
YES
Study ID_1
JMA-IIA00075
Org. issuing International ID_1
JMACCT CTR
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広瀬クリニック（愛知県）、メドック健康クリニック（愛知県）、三本木クリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ecme.adaptgen.co.jp/clinical.html
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2013 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008179
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
