UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020379 |
|---|---|
| Receipt number | R000023501 |
| Scientific Title | Plastic Surgery for HIV facial lipoatrophy |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2019/04/26 11:02:43 |
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Basic information
Public title
Plastic Surgery for HIV facial lipoatrophy
Acronym
Plastic Surgery for HIV facial lipoatrophy
Scientific Title
Plastic Surgery for HIV facial lipoatrophy
Scientific Title:Acronym
Plastic Surgery for HIV facial lipoatrophy
Region
| Japan |
Condition
Condition
HIV facial lipoatrophy
Classification by specialty
| Infectious disease | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of safety and efficacy of plastic surgery approach to HIV facial lipoatrophy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quantitative and qualitative evaluation of the facial soft tissue at 48 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
autologous fat transplantation
Interventions/Control_2
dermal filler (hyaluronic acid) administeration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
well controlled HIV infection
Key exclusion criteria
platelet count lower than 50000/mm3
pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Oka |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
oka@acc.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihisa Tsukada |
Organization
National Center for Global Health and Medicine
Division name
AIDS Clinical Center
Zip code
Address
1-21-1, Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
Homepage URL
ktsukada@acc.ncgm.go.jp
Sponsor or person
Institute
AIDS Clinical Center, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
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
| 2015 | Year | 12 | Month | 28 | 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
| 2014 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023501
