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IRCT201108097270N1 IRCT 2012-01-27 Skin research center, Shohada-e-Tajrish hospital New way to treating the smile lines The evaluation of efficacy and adverse effects of subcision in the correction of nasolabial fold 2012-02-01 anticipated 10 Complete https://irct.ir/trial/7710 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A improvement of nasolabial fold by subcision. At first, the desired area is marked and local anesthesia is undergone using lidocain 1%. The subcision needle penetrates the skin from the margin of the nasolabial fold while its sharp edge is upward. The needle will be rotated till its tip become parallel to the dermoepidermal junction. The necessary movement will be done for releasing the fibrotic band .. http://www.hindawi.com/journals/drp/2015/976153/ The evaluation of efficacy and adverse effects of subcision in the correction of nasolabial fold <br /> <br /> Background. A prominent nasolabial fold (NLF) is a cosmetic problem. Currently, numerous therapeutic modalities are available<br /> for pronounced NLFs with variable efficacy. Objective. To determine the efficacy and safety of subcision using a hypodermic needle<br /> for the correction of the prominentNLFs and its effect on skin elasticity. Methods. Sixteen patients with prominentNLFs underwent<br /> subcision. The investigators’ assessment of improvement and the patients’ satisfaction were both recorded 1 and 6 months after the<br /> procedure. Also,we evaluate the skin elasticity of NLFs before and after the treatment using a sensitive biometrologic device with the<br /> measurement of cutaneous resonance running time (CRRT). Results. Thirteen (81.25%) patients showed a moderate improvement<br /> at 1stmonth and 13 (81.25%) patients had at least a mild improvement at 6th month. There was no persistent side effect lasting more<br /> than a few days. Mean CRRT at 1 and 6 months after the treatment was significantly higher compared to the baseline. Conclusion.<br /> Subcision may be considered effective for the correction of pronounced NLFs. However, further controlled studies with larger<br /> sample size are necessary to assess the efficacy of this technique in particular with use ofmore objective assessment of skin biometric<br /> characteristics. This trial is registered with IRCT201108097270N1 (registered on January 27, 2012).
public Reza Mahmoud Robati
Skin Research Center, Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 2274 1507 robati@razi.tums.ac.ir Skin Research Center, Shahid Beheshti University of Medical Sciences scientific Reza Mahmoud Robati
Skin Research Center, Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 2274 1507 rezarobati@sbmu.ac.ir Skin Research Center, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. age 30-60y; 2.deep nasolabial fold. Exclusion criteria:1.age under 30y; 2.lactation & pregnancy; 3.history of coagulopathy or use of anticouagulant drug; 4.active infection in facial zone; 5.inability to stay in the study; 6.history of collagen or elastin disorder and connective tissue disease; 7.history of facial skin cancer; 8.history of topical medication administration during 1 month before study except sunscreen; 9.history of cosmetic procedure during last year (laser,..); 10. history of filler injection in nasolabial fold during last 5 years. 30 years 60 years Both Z41.9 Procedure for purposes other than remedying health state, unspecified Treatment - Surgery At first, the desired area is marked and local anesthesia is undergone using lidocain 1%. The subcision needle penetrates the skin from the margin of the nasolabial fold while its sharp edge is upward. The needle will be rotated till its tip become parallel to the dermoepidermal junction. The necessary movement will be done for releasing the fibrotic band . Nasolabial fold. Timepoint: before treatment,1 w, 1 m and 6 m after treatment. Method of measurement: photograph,reviscometer. Bleeding. Timepoint: immediately after treatment and the day after. Method of measurement: observation. Ecchymosis. Timepoint: 2 hours ,1 day and 1 week after treatment. Method of measurement: observation. Infection. Timepoint: 1 w after treatment. Method of measurement: physical exam. Skin research center, Shohada-e-Tajrish hospital Approved 2011-10-16 Skin research center ethics committe, Shahid Beheshti University of Medical Sciences Shohada-e-Tajrish hospital, Shahid Beheshti University of Medical Sciences Tehran Iran (Islamic Republic of)