Condition(s) treated: Scar

Intervention: pulsed dye laser therapy (Procedure)

Enrollment status: Recruiting

Sponsor: Tehran University of Medical Sciences

Principal investigator(s) or official(s):
Alireza Firooz, MD, Principal Investigator, Affiliation: Tehran University of Medical Sciences

Overall contact:
Parastoo Davari, MD, Phone: 00989123711337, Email: davaripa@yahoo.com

The appearance of skin after surgery plays an important role in patient's self confidence and life style. In fact, Keloids and hypertrophic scars are abnormal wound responses appearing in predisposed individuals after surgery. Among different kind of lasers, used to improve the appearance of hypertrophic scars and keloids, pulsed dye laser is now being used successfully in treatment of scars. Pulsed dye laser is effective in improving the color, height, texture, and elasticity of scars. Also, treatment with this technique is noninvasive, minimally uncomfortable, and requires no anesthesia. This study will assess the efficacy and safety of different intervals of pulsed dye laser sessions on improvement of surgical scars.

Official title: The Effect of Different Intervals of 595-nm Pulsed Dye Laser Sessions on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial

Study design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study

Primary outcome: pigmentation, pliability, width and height of surgical scars (Time Frame: baseline, middle of the study, 1 and 3 months after the last treatment session)

Secondary outcome: 1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events (Time Frame: 1 and 3 months after the last treatment session)

Minimum eligible age: 18 Years. Maximum eligible age: 80 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Surgical scar with minimum length of 6 cm

Exclusion Criteria:

- History of light sensitivity or photodermatoses

- History of adverse reactions to laser treatment

Parastoo Davari, MD, Phone: 00989123711337, Email: davaripa@yahoo.com

Center for research and training in skin diseases and leprosy, Tehran 14166, Iran, Islamic Republic of; Recruiting
Alireza Firooz, MD, Principal Investigator

Related publications:

Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73.

Conologue TD, Norwood C. Treatment of surgical scars with the cryogen-cooled 595 nm pulsed dye laser starting on the day of suture removal. Dermatol Surg. 2006 Jan;32(1):13-20.

Paquet P, Hermanns JF, Pierard GE. Effect of the 585 nm flashlamp-pumped pulsed dye laser for the treatment of keloids. Dermatol Surg. 2001 Feb;27(2):171-4.

Alster TS, Williams CM. Treatment of keloid sternotomy scars with 585 nm flashlamp-pumped pulsed-dye laser. Lancet. 1995 May 13;345(8959):1198-200.

Alam M, Pon K, Van Laborde S, Kaminer MS, Arndt KA, Dover JS. Clinical effect of a single pulsed dye laser treatment of fresh surgical scars: randomized controlled trial. Dermatol Surg. 2006 Jan;32(1):21-5.

Manuskiatti W, Wanitphakdeedecha R, Fitzpatrick RE. Effect of pulse width of a 595-nm flashlamp-pumped pulsed dye laser on the treatment response of keloidal and hypertrophic sternotomy scars. Dermatol Surg. 2007 Feb;33(2):152-61.

Start date: July 2007
End date: January 2009
Last updated: January 13, 2008

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