Clinical trial NCT00506090: Safety and Efficacy 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scar
Keywords: scar
surgery
lasers
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: pigmentation, pliability, width and height of surgical scars
timeFrame: baseline, middle of the study, 1 and 3 months after the last treatment session
Secondary outcomes:
measure: 1- Clinical appearance of surgical scars 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) 3- Adverse events
timeFrame: 1 and 3 months after the last treatment session
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Center for research and training in skin diseases and leprosy
Study officials:
affiliation: Tehran University of Medical Sciences
name: Alireza Firooz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1046/j.1524-4725.2003.29014.x.
citation: 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. doi: 10.1111/1524-4725.2006.32002.
citation: 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. doi: 10.1046/j.1524-4725.2001.00169.x.
citation: 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. doi: 10.1016/s0140-6736(95)91989-9.
citation: 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. doi: 10.1111/1524-4725.2006.32029.
citation: 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. doi: 10.1111/j.1524-4725.2006.33033.x.