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Safety and Efficacy of Different Onset Times of Treatment With Pulsed Dye Laser on Improvement of Surgical Scars

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ClinicalTrials.gov Identifier: NCT00506363
Recruitment Status : Terminated (The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.)
First Posted : July 25, 2007
Last Update Posted : October 6, 2009
Sponsor:
Information provided by:

Study Description
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 onset times of treatment with pulsed dye laser on improvement of surgical scars.

Condition or disease Intervention/treatment
Scar Procedure: pulsed dye laser therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Different Onset Times of Treatment With 595-nm Pulsed Dye Laser on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial
Study Start Date : January 2008
Primary Completion Date : December 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
pulsed dye laser and dynamic cooling device on the day of suture removal
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
Active Comparator: B
pulsed dye laser and dynamic cooling device 2 months after suture removal
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.
Sham Comparator: C
dynamic cooling device
Procedure: pulsed dye laser therapy
Each scar will be divided into 3 equal parts. One part will be randomly allocated to be treated with pulsed dye laser and dynamic cooling device on the day of suture removal. Another part will be treated with pulsed dye laser and dynamic cooling device 2 months after suture removal. Only dynamic cooling device will be used for remaining part serving as control. Treatment will repeat for 6 sessions at 3 weeks intervals.


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 1- Clinical appearance of scar 2- Patient's satisfaction (scar erythema, scar thickness and scar induration) - Adverse events [ Time Frame: 1 and 3 months after the last treatment session ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506363


Locations
Iran, Islamic Republic of
Center for research and training in skin diseases and leprosy
Tehran, Iran, Islamic Republic of, 14166
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Alireza Firooz, MD Tehran University of Medical Sciences
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00506363     History of Changes
Other Study ID Numbers: 423/2224-B
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: October 6, 2009
Last Verified: October 2009

Keywords provided by Tehran University of Medical Sciences:
scar
surgery
lasers