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

This study has been terminated.
(The trial was terminated on May 2008 after inclusion of 10 patients due to low recruitment and patient compliance.)
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00506363
First received: July 23, 2007
Last updated: October 4, 2009
Last verified: October 2009
  Purpose

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 Intervention
Scar
Procedure: pulsed dye laser therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • pigmentation, pliability, width and height of surgical scars [ Time Frame: baseline, middle of the study, 1 and 3 months after the last treatment session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: July 23, 2007
Last Updated: October 4, 2009
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on October 21, 2014