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This study has been withdrawn prior to enrollment.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:
Tehran University of Medical Sciences
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 23, 2007 | ||||
| Last Updated Date | October 4, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
pigmentation, pliability, width and height of surgical scars [ Time Frame: baseline, middle of the study, 1 and 3 months after the last treatment session ] | ||||
| Change History | Complete list of historical versions of study NCT00506090 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Different Intervals of Pulsed Dye Laser Sessions on Improvement of Surgical Scars | ||||
| Official Title ICMJE | The Effect of Different Intervals of 595-nm Pulsed Dye Laser Sessions on Improvement of Surgical Scars: A Double Blind Randomised Clinical Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Scar | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00506090 | ||||
| Other Study ID Numbers ICMJE | 423/2224-A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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