UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000001208
Receipt number	R000001473
Scientific Title	Treatment of Keloids and Hypertrophic Scars with a Long-pulsed Nd:YAG Laser in non-contact mode
Date of disclosure of the study information	2008/12/31
Last modified on	2008/06/24 19:05:14

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Basic information

Public title

Treatment of Keloids and Hypertrophic Scars with a Long-pulsed Nd:YAG Laser in non-contact mode

Acronym

Treatment of Keloids and Hypertrophic Scars with a Long-pulsed Nd:YAG Laser in non-contact mode

Scientific Title

Treatment of Keloids and Hypertrophic Scars with a Long-pulsed Nd:YAG Laser in non-contact mode

Scientific Title:Acronym

Treatment of Keloids and Hypertrophic Scars with a Long-pulsed Nd:YAG Laser in non-contact mode

Region

Japan

Condition

keloids and hypertrophic scars

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

We have used the long-pulsed 1064-nm Nd:YAG laser to treat keloids and hypertrophic scars since 2006. Here, we investigated the efficacy, adaptability, and limitations of this method for keloid and hypertrophic scar management. Moreover, we sought to elucidate the mechanism that mediates its efficacy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Assessment

Primary outcomes

The patients were treated every 3 to 4 weeks with the long-pulsed 1064-nm Nd:YAG laser (GenesisTM, Cutera Inc., Brisbane, CA, USA), which was applied in non-contact mode with a spot size that was 5 mm in diameter, an energy density of 14 J/cm2, an exposure time per pulse of 0.3 msec, and a repetition rate of 10 Hz. 500 to 1000 pulses per cm2. The frequency of irradiation ranged from 5 to 49 exposures and averaged 14.05 exposures. The response of the scars to the laser treatment was assessed by measuring the following five parameters: color, degree of hypertrophy, hardness of hypertrophy, itching, spontaneous pain, and tenderness. The assessments were performed by two experienced physicians (S.K. and R.O.) before the treatments started and after they were completed. Scoring was based on a 4-point scale ranging from 0 to 3 (0 = absent; 1 = mild; 2 = moderate; 3 = severe. In other words, the maximum possible score for a patient was 15 points.

Key secondary outcomes

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects were 22 Japanese patients (four males and 18 females) with a mean age of 34.95 years. Of these patients, 16 had keloids and six had hypertrophic scars. We defined keloids as scars that extended beyond the confines of the original wound.

Key exclusion criteria

none received any other treatment

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Satoshi Akaishi

Organization

Nippon Medical School Hospital

Division name

Plastic, Reconstructive and Aesthetic Surgery

Zip code

Address

1-1-5, sendagi, bunkyou-ku, Tokyo, Japan

TEL

03-3822-2131

Email

Public contact

Name of contact person

1st name

Middle name

Last name Satoshi Akaishi

Organization

Nippon Medical School Hospital

Division name

Plastic, Reconstructive and Aesthetic Surgery

Zip code

Address

1-1-5, sendagi, bunkyou-ku, Tokyo, Japan

TEL

03-3822-2131

Homepage URL

Email

redstoneprs@gmail.com

Sponsor or person

Institute

Plastic, Reconstructive and Aesthetic Surgery, Nippon Medical School

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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2008 Year 12 Month 31 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

No longer recruiting

Date of protocol fixation

2006 Year 01 Month 01 Day

Date of IRB

Anticipated trial start date

2006 Year 04 Month 01 Day

Last follow-up date

2010 Year 03 Month 01 Day

Date of closure to data entry

2010 Year 03 Month 01 Day

Date trial data considered complete

2010 Year 03 Month 01 Day

Date analysis concluded

2010 Year 03 Month 01 Day

Other

Other related information

prospective study

Management information

Registered date

2008 Year 06 Month 24 Day

Last modified on

2008 Year 06 Month 24 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001473

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name