UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012511 |
|---|---|
| Receipt number | R000014627 |
| Scientific Title | An immunohistological study of the human skin before and after application of cosmetic lotions containing various molecular sizes of hyaluronan and a supplementary study about ability of steroid production in epidermis by application of ACTH. |
| Date of disclosure of the study information | 2013/12/31 |
| Last modified on | 2014/11/13 22:16:18 |
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Basic information
Public title
An immunohistological study of the human skin before and after application of cosmetic lotions containing various molecular sizes of hyaluronan and a supplementary study about ability of steroid production in epidermis by application of ACTH.
Acronym
Immunohistological changes of human skin by hyaluronan lotion and the epidermis ACTH loading test.
Scientific Title
An immunohistological study of the human skin before and after application of cosmetic lotions containing various molecular sizes of hyaluronan and a supplementary study about ability of steroid production in epidermis by application of ACTH.
Scientific Title:Acronym
Immunohistological changes of human skin by hyaluronan lotion and the epidermis ACTH loading test.
Region
| Japan |
Condition
Condition
1.aged skin
2.atopic dermatitis
Classification by specialty
| Dermatology | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of hyaluronan lotion application to 1) aged skin 2) atopic dermatitis. To confirm steroid production ability of epidermis at the same time in the latter in which the effect might be different according to topical steroid application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Immunohistological changes before and after application of hyaluronan lotion for two weeks.
Key secondary outcomes
Immunohistological changes before and after application of ACTH lotion for two weeks.
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
External application of hyaluronan lotion twice a day for two weeks.
External application of ACTH solution also twice a day for two weeks in patients with atopic dermatitis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible over 60 years old in aged skin subjects.
Key exclusion criteria
Ineligible under 60 years old in aged skin subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu Fukaya |
Organization
Tsurumai Kouen Clinic
Division name
Cosmetic surgery and dermatology
Zip code
Address
5-20-6 Choyoda Nakaku Nagoya 460-0012 Japan
TEL
+81-52-264-0212
moto@earth.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Fukaya |
Organization
Tsurumai Kouen Clinic
Division name
Cosmetic surgery and dermatolgy
Zip code
Address
5-20-6 Choyoda Nakaku Nagoya 460-0012 Japan
TEL
+81-52-264-0212
Homepage URL
moto@earth.ocn.ne.jp
Sponsor or person
Institute
Tsurumai Kouen Clinic
Institute
Department
Personal name
Funding Source
Organization
Tsurumai Kouen Clinic
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=46333
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
| 2013 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 11 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 06 | Day |
Last modified on
| 2014 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014627
