UMIN-CTR Clinical Trial

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

malasma

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Improvement of pigmentation when luminosity is changed, using a skin tone color scale

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Non-Profit Organization Health Institute Research of Skin

Institute

Department

Personal name

Organization

JMEC Co., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

11

Month

05

Day

Last modified on

2018

Year

08

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022291