｜NIPH Clinical Trials Search

UMIN ID: UMIN000001208

Registered date:31/12/2008

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

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	keloids and hypertrophic scars
Date of first enrollment	2006/04/01
Target sample size	20
Countries of recruitment	Japan
Study type	Observational
Intervention(s)

TO Original Data: UMIN

Outcome(s)

Primary Outcome	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.
Secondary Outcome

Primary Outcome

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.

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	none received any other treatment

Related Information

Primary Sponsor	Plastic, Reconstructive and Aesthetic Surgery, Nippon Medical School
Secondary Sponsor
Source(s) of Monetary Support	none
Secondary ID(s)

Contact

public contact
Name	Satoshi Akaishi
Address	1-1-5, sendagi, bunkyou-ku, Tokyo, Japan Japan
Telephone	03-3822-2131
E-mail	redstoneprs@gmail.com
Affiliation	Nippon Medical School Hospital Plastic, Reconstructive and Aesthetic Surgery
scientific contact
Name	Satoshi Akaishi
Address	1-1-5, sendagi, bunkyou-ku, Tokyo, Japan Japan
Telephone	03-3822-2131
E-mail
Affiliation	Nippon Medical School Hospital Plastic, Reconstructive and Aesthetic Surgery

TO Original Data: UMIN