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Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars

This study has been withdrawn prior to enrollment.
(Because of unsatisfactory results of previous trial which assessed the effect of different onset times of PDL on surgical scars.)
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00506090
First received: July 23, 2007
Last updated: October 4, 2009
Last verified: October 2009
History of Changes
  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 intervals of pulsed dye laser sessions 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 Intervals of 595-nm Pulsed Dye Laser Sessions on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

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 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2007
Arms Assigned Interventions
Experimental: A
pulsed dye laser and dynamic cooling device at 3 weeks intervals
 Procedure: pulsed dye laser therapy
Treatment will begin on the day of suture removal. 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 at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.
Active Comparator: B
pulsed dye laser and dynamic cooling device at 6 weeks intervals
 Procedure: pulsed dye laser therapy
Treatment will begin on the day of suture removal. 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 at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.
Sham Comparator: C
dynamic cooling device
 Procedure: pulsed dye laser therapy
Treatment will begin on the day of suture removal. 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 at 3 weeks intervals for 6 sessions. Another part will be treated with pulsed dye laser and dynamic cooling device at 6 weeks intervals for 6 sessions. Only dynamic cooling device will be used for remaining part serving as control.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506090

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:

Responsible Party: Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00506090     History of Changes
Other Study ID Numbers: 423/2224-A
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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013