UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004877
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email dertom55@yahoo.co.jp

Sponsor
Institute Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.