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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001208
Receipt No. 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

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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
Condition keloids and hypertrophic scars
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

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 20

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
Institute Plastic, Reconstructive and Aesthetic Surgery, Nippon Medical School
Institute
Department

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
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
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
URL(English) https://upload.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


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