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| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2007 | ||||
| Last Updated Date | October 4, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | |||||
| 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 ] | ||||
| 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 | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Scar | ||||
| Intervention ICMJE | Procedure: pulsed dye laser therapy | ||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| 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 ID ICMJE | NCT00506090 | ||||
| Responsible Party | Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences | ||||
| Study ID Numbers ICMJE | 423/2224-A | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | |||||
| 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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