UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010204
Receipt number 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 10:47:19

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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 or person

Institute

Department of Plastic and Reconstructive Surgery, University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.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