UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004877 |
|---|---|
| Receipt number | R000005787 |
| Scientific Title | The effect of collagen tripeptide for patients with atopic dermatitis |
| Date of disclosure of the study information | 2011/01/14 |
| Last modified on | 2019/09/14 05:39:45 |
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Basic information
Public title
The effect of collagen tripeptide for patients with atopic dermatitis
Acronym
The effect of collagen tripeptide for patients with atopic dermatitis
Scientific Title
The effect of collagen tripeptide for patients with atopic dermatitis
Scientific Title:Acronym
The effect of collagen tripeptide for patients with atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of oral collagen tripeptide, or topical liquid application containing collagen tripeptide in patients with atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
trans epidermal water loss(TEWL), stratum corneum hydration and visual analog scale were measured at 2-week intervals for 6 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The volunteer with mild-to-moderate atopic dermatitis were given an 4-week treatment with oral collagen tripeptide (4g/day).
Interventions/Control_2
The volunteer with mild-to-moderate atopic dermatitis were given an 4-week treatment with oral lactose (2g/day) as placebo control.
Interventions/Control_3
The volunteer with mild-to-moderate atopic dermatitis were given an 4-week treatment with topical application containing collagen tripeptide on both sides of upper arms(15ml/each arms)more than 2 times per day.
Interventions/Control_4
The volunteer with mild-to-moderate atopic dermatitis were given an 4-week treatment with topical placebo-applicatio(without collagen tripeptide) on both sides of upper arms(15ml/each arms)more than 2 times per day.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The patients with mild-to-moderate atopic dermatit
2) Male or female subjects (18 to 90 years old)
Key exclusion criteria
1) Under treatment of steroid or cyclosporine A orally
2) Under phototherapy on upper arms
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yukie |
| Middle name | |
| Last name | Yamaguchi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Environmental Immuno-Dermatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004,
TEL
045-787-2675
yui1783@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Okawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Environmental Immuno-Dermatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
TEL
045-787-2675
Homepage URL
dertom55@yahoo.co.jp
Sponsor or person
Institute
Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Graduate School of Medicine
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004
Tel
045-787-2511
u_syomu@yokohama-cu.ac.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
| 2011 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
http://dx.doi.org/10.1016/j.jdermsci.2017.09.002
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1016/j.jdermsci.2017.09.002
Number of participants that the trial has enrolled
17
Results
Seventeen AD patients were assigned randomly. Four patients dropped out of. The eruption area and SCORAD score were significantly decreased in theCTP group. TEWL levels were improved in the CTP group. Skin hydration tended to elevate, but did not reach statistical significant.In blood samples, a significantly reduction in the TARC level was seen only CTP group. The levels of serum LDH and IgE were not changed in either group. In the control group, eosinophil counts were increased compared to baseline.
Results date posted
| 2019 | Year | 09 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Atopic dermatitis patients with mild to moderate disease.
Participant flow
Patients were allowed to use their daily topical products, except on one upper arm.
Eligible patients were assigned randomly under double-blind conditions to receive either a CTP product or normal collagen which does not contain CTP.
Peptides were administered orally for 12 weeks.
Adverse events
None
Outcome measures
the eruption area, SCORAD score, TEWL, Skin hydration
Serum TARC level, LDH level, IgE level
eosinophil counts
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 29 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005787
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