UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004986 |
|---|---|
| Receipt number | R000005929 |
| Scientific Title | The prospective study about the color change and reproducibility in the nipple areola tattoo |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2024/08/11 21:51:26 |
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Basic information
Public title
The prospective study about the color change and reproducibility in the nipple areola tattoo
Acronym
The prospective study about the color change and reproducibility in the nipple areola tattoo
Scientific Title
The prospective study about the color change and reproducibility in the nipple areola tattoo
Scientific Title:Acronym
The prospective study about the color change and reproducibility in the nipple areola tattoo
Region
| Japan |
Condition
Condition
nipple areola color asymmetry
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the color change, the color reproducibility, and the difference by the skin thickness in a medical tattoo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on a clinical photograph (pre-ope, post 1 week, post 1 month, post 3 months, post 6 months, post 1 year), we evaluate the difference with the color chart, the difference with the normal side, the serial change of color using an index (a histogram mean) of the brightness.
Key secondary outcomes
Furthermore, We evaluate the color difference due to the type of the breast reconstruction.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The women (20 years or older) who can judge to participate in a study by own intention.
Key exclusion criteria
When subjects choose not to participate in a study, or withdraw the declaration of participating intention.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Mori |
Organization
Tokyo Medical and Dental University
Division name
Plastic and Reconstructive surgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
81-3-5803-5923
moriplas@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Mori |
Organization
Tokyo Medical and Dental University
Division name
Plastic and Reconstructive surgery
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
81-3-5803-5923
Homepage URL
moriplas@tmd.ac.jp
Sponsor or person
Institute
Plastic and Reconstructive surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Medical and Dental univ
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-3813-6111
tiken.crc@tmd.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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-2309-2731.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/pdf/10.1055/a-2309-2731.pdf
Number of participants that the trial has enrolled
60
Results
RGB varied widely from immediately after to 1 month after tattooing. For RGB and luminance, significant differences were seen between pre and immediate after, 1 and 3 months, 3 and 6 months, and 6 and 12 months. The fading rate tended to decrease as time progresses, but was not significant. Luminance was 9% brighter than contralateral NAC at 12 months. Color reproducibility tended to be higher with dark/reddish pigments, despite no significant differences.
Results date posted
| 2024 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient, n 59 (60 sites)Age (years) 51.3 (SD 9.3)
Breast reconstruction: Abdominal flap 32Latissimus dorsi flap 13Breast implant 14Breast conservation surgery 1 with nipple resection
Nipple reconstruction: Modified CV flap 60
Participant flow
Study 1: Red, Green, and Blue, and Luminance Changes Over Time
This analysis was performed at 46 sites of 45 patients, after excluding 4 sites in 4 patients who dropped out, 5 sites in 5 patients who received a second tattoo within a year, and 4 sites in 4 patients for whom data were missing .
Study 2: Reproducibility of Color
The analysis was performed for 34 sites in 33 patients after excluding 4 sites in 4 patients who dropped out, 2 sites in 2 patients with 2 unknown pigments, 17 sites in 17 patients with pigments used at less than 4 sites, and 3 sites in 3 patients (flesh2.5: 1, flesh4: 2) who received a second tattoo within a year.
Adverse events
none
Outcome measures
Change over time in RGB, luminance, and comparison of RGB and luminance with the healthy side after one year
Colour reproducibility of each colour
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
prospective study
published
Management information
Registered date
| 2011 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005929
