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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019640
Receipt No. R000022291
Scientific Title Study of the utility of laser toning for chloasma
Date of disclosure of the study information 2015/12/01
Last modified on 2018/08/22

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Basic information
Public title Study of the utility of laser toning for chloasma
Acronym Study of the utility of laser toning for chloasma
Scientific Title Study of the utility of laser toning for chloasma
Scientific Title:Acronym Study of the utility of laser toning for chloasma
Region
Japan

Condition
Condition malasma
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to examine the utility of laser toning in treatment of chloasma by evaluating the efficacy and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of pigmentation when luminosity is changed, using a skin tone color scale
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
Device,equipment
Interventions/Control_1 1) Commencement of induction therapy: Tranexamic acid (750-1,500 mg/day) in two divided doses administered in the morning and evening every day for 8 weeks.
When sufficient improvement of chloasma is confirmed after completion of the induction therapy, the study is terminated for the subject.
2) Commencement of WO: WO of tranexamic acid is performed.
3) Commencement of LT: 1 cycle of LT treatment is performed.
4) Commencement of FU: Follow-up observation is performed after LT treatment.
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 Male and Female
Key inclusion criteria 1) Typical patients with chloasma with clear pigmentations aged 20 years old or older
2) Patients who voluntarily provided written informed consent after receiving an explanation of the details of the study
Key exclusion criteria 1) Patients receiving laser toning for chloasma or with experience of such treatment
2) Patients with a history of rheumatism or administration of a gold drug, and those receiving an iron preparation
3) Patients who have or are suspected to have a precancerous lesion or a malignant tumor
4) Patients with photosensitivity and those receiving a drug to enhance photosensitivity
5) Patients who had received treatment with gold string
6) Patients with cardiac disease (serious heart disease or use of a cardiac pacemaker)
7) Patients with hemorrhagic disease or those receiving an anticoagulant (bayaspirin, warfarin, etc.)
8) Patients with possible delayed wound healing (diabetes, connective tissue disease, etc.)
9) Patients with skin disease other than chloasma at irradiated sites
10) Patients with hypersensitive skin (hives, atopic dermatitis, allergic diathesis, etc.)
11) Patients with inflammation at the sites of chloasma
12) Patients receiving hormone replacement therapy
13) Patients who have taken a steroid preparation for a long period of time
14) Pregnant women, those who may be pregnant, lactating women, and women who hope to become pregnant during the study period
15) Patients who may be highly exposed to sunlight through repeated daily daytime outdoor sports activities
16) Patients with sunburnt skin or with the possibility of sunburn after treatment
17) Patients participating in another clinical study at the start of this study
18) Patients with a history of serious disease
19) Other patients who were considered inappropriate to participate in the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kawashima
Organization Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
Division name Department of Dermatology
Zip code
Address 8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email m-kawash@derm.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Kanazawa
Organization EBC&M LLC.
Division name Project planning & Development department
Zip code
Address CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
TEL 03-6435-3833
Homepage URL
Email naomi_kanazawa@ebc-m.com

Sponsor
Institute Non-Profit Organization Health Institute Research of Skin
Institute
Department

Funding Source
Organization JMEC 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
2015 Year 12 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
2015 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 05 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022291

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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