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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010204
Receipt No. R000011950
Scientific Title Clinical studies on the usefulness of sunscreens in the treatment of skin pigmentation disease
Date of disclosure of the study information 2013/04/01
Last modified on 2015/09/10

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Basic information
Public title Clinical studies on the usefulness of sunscreens in the treatment of skin pigmentation disease
Acronym Clinical studies on the usefulness of sunscreens in the treatment of skin pigmentation disease
Scientific Title Clinical studies on the usefulness of sunscreens in the treatment of skin pigmentation disease
Scientific Title:Acronym Clinical studies on the usefulness of sunscreens in the treatment of skin pigmentation disease
Region
Japan

Condition
Condition Skin pigmentation disease
Classification by specialty
Dermatology Plastic surgery Aesthetic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, to verify the improvement effect of standard treatment by the use of after suture or skin graft and the treatment of skin pigmentation various generated at the site of exposure to sunscreens with high masking effect and UV protective effect of skin performed.
As evaluation criteria to analyze trends, such as cytokines associated with the production of melanin in the stratum corneum of the skin color changes and figures by colorimeter. As a secondary outcome, satisfaction of the subject: to investigate (QOL Skindex-16).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At the first visit (before start of the application), and the observation and measurement of the following (after 8 weeks) after 4 weeks and at the end.

skin findings
Observe the treatment site, fill in the card case is determined at step 5 the state of erythema and eschar.

photography
Taken by a digital camera the treatment site.

skin color
Measured by (CM-2600d Konica Minolta) spectral colorimeter skin color or skin graft or suture site site (healthy) and its marginal treatment site.

Collected stratum corneum by tape stripping
Collecting the outermost layer of the stratum corneum site (healthy) and marginal treatment site by:Sellotape

(only at the beginning and end) QOL survey
The investigation by Skindex-16 is a measure of the subject-specific QOL skin.
Key secondary outcomes

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 Product from this study (three sunscreens), to select one or more, depending on the UV shielding effect of the treatment sought.
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 attribute
Patients with skin pigmentation, skin graft patient, patient suture
Key exclusion criteria
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Sekido
Organization University of Tsukuba
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Tennodai 1-1-1, Tsukuba, Ibaraki 305-8577, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Adachi
Organization University of Tsukuba
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL 029-853-3000
Homepage URL
Email

Sponsor
Institute Department of Plastic and Reconstructive Surgery, University of Tsukuba
Institute
Department

Funding Source
Organization TOKIWA Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 01 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
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2015 Year 09 Month 10 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 10 Day
Last modified on
2015 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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