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IRCT20141228020468N5 IRCT 2019-09-11 Shahid Beheshti University of Medical Sciences Efficacy and safety of different modalities in the treatment of seborrheic keratosis A comparative study of efficacy and safety of cryosurgery, electrocoagulation, CO2 laser and Erbium:YAG laser in the treatment of seborrheic keratoses 2019-04-21 anticipated 32 Complete https://irct.ir/trial/39429 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 4 seborrheic keratoses with similar size and thickness on the patients face are randomly chosen and numbered from 1 to 4 and written on a set of cards ;treatment modalities are also randomly named A,B,C or D and written on another set of cards.A blinded person chooses a number from 1 to 4 from the first group and a letter from the second group representing the treatment modality, Blinding description: In our study investigators and the assessors of the outcomes are also unaware of the study groups. 4 seborrheic keratoses with similar size and thickness on the patients face are randomly chosen and numbered from 1 to 4 and written on a set of cards ;treatment modalities are also randomly named A,B,C or D and written on another set of cards.A blinded person chooses a number from 1 to 4 from the first group and a letter from the second group representing the treatment modality.Assessment of the final results is done by 2 dermatologists who are unaware of the treatment used for any of the lesions and is based on the photographs . N/A seborrheic keratosis. Intervention 1: Control group 1: Electrodessication with the same parameters on seborrheic keratosis lesions. The electrodessication (electrosurgical unit, MEG1, Iran Kavandish System co, made in Iran, 2013) is performed by the mode of biterminal monopolar on seborrheic keratosis lesions with the same parameters and with low energy in one treatment session. Intervention 2: Control group 2: Cryosurgery with the same parameters on seborrheic keratosis lesions. In all patients, cryotherapy is performed with the application of liquid nitrogen with an open-spray for a single 10 to a 15-second freeze-thaw cycle and in one treatment session. Intervention 3: Intervention group 1: Er: YAG laser with the same parameters on seborrheic keratosis lesions. The next device used is Er: YAG laser, LOTUS II erbium device (LOTUS II; Laseroptek Co., Ltd., Sungnam, Gyenggido, Korea). We applied the energy of 500 MJ, with a spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size. Intervention 4: Intervention group 2: Co2 laser with the same parameters on seborrheic keratosis lesions. The CO2 laser used in the study is a fractional CO2 laser (Mixel; Hironic Co., Ltd, Korea). We applied the energy of 1.5 J / cm2, pulse duration of 0.4 sec and spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size. Yes - There is a plan to make this available What will be shared: All collected demographic data and primary and secondary outcomes are going to be shared after de-identification of the participants. When: These data files will become available starting 6 months after publication. To whom: The deidentified IPD and additional supporting information/documents will be available for people working in academic institutions. Conditions: None Where to obtain: To access the data files applicant can talk to Dr. Shirin Zaresharifi resident of dermatology at Shahid Beheshti University of Medical Sciences. Address: Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran Postal code: 1985717443 Email address:shirin.zsharifi@sbmu.ac.ir Phone number: 0098 21 2243 9982 Mobile number: 0098 912 846 5784 How to obtain: The applicants should follow Shahid Beheshti University of Medical Sciences process and protocols for accessing the data files. Comments:
public Shirin Zaresharifi
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9982 shirin.zsharifi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr Reza Robati
Shahid Beheshti University of Medical Sciences, Velenjak, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 19839-63113 +98 21 2274 1508 rezarobati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 35 to 85 All participants should have at least 4 seborrheic keratoses with similar size and thickness on face 35 years 85 years Both History of keloid History of coagulopathy or anticoagulant treatment Uncontrolled diabetes Uncontrolled hypertension Active infection on face Non-compliance with treatment and follow ups History of autoimmune connective tissue disease Known allergy to lidocaine or tetracaine Cold intolerance Cryoglobulinemia Cold urticaria and any kind of cold rash L82 Seborrheic keratosis Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control group 1: Electrodessication with the same parameters on seborrheic keratosis lesions. The electrodessication (electrosurgical unit, MEG1, Iran Kavandish System co, made in Iran, 2013) is performed by the mode of biterminal monopolar on seborrheic keratosis lesions with the same parameters and with low energy in one treatment session. Control group 2: Cryosurgery with the same parameters on seborrheic keratosis lesions. In all patients, cryotherapy is performed with the application of liquid nitrogen with an open-spray for a single 10 to a 15-second freeze-thaw cycle and in one treatment session. Intervention group 1: Er: YAG laser with the same parameters on seborrheic keratosis lesions. The next device used is Er: YAG laser, LOTUS II erbium device (LOTUS II; Laseroptek Co., Ltd., Sungnam, Gyenggido, Korea). We applied the energy of 500 MJ, with a spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size. Intervention group 2: Co2 laser with the same parameters on seborrheic keratosis lesions. The CO2 laser used in the study is a fractional CO2 laser (Mixel; Hironic Co., Ltd, Korea). We applied the energy of 1.5 J / cm2, pulse duration of 0.4 sec and spot size of 4 mm. All lesions were treated in one session and they received the same amount of energy, fluence, pulse duration, and spot size. The rate of recovery of seborrheic keratosis. Timepoint: Before the intervention and 2, 8 weeks after the intervention. Method of measurement: Photography before procedure and in follow up intervals, patient satisfaction. Pain. Timepoint: Immediately after the intervention and 2, 8 weeks after the intervention. Method of measurement: Asking the patients. Dyspigmentation. Timepoint: Before the intervention and 2, 8 weeks after the intervention. Method of measurement: Evaluation of patients photographs by two dermatologists. Scar. Timepoint: Before the intervention and 2, 8 weeks after the intervention. Method of measurement: Evaluation of patients photographs by two dermatologists. Keloid formation. Timepoint: Before the intervention and 2, 8 weeks after the intervention. Method of measurement: Evaluation of patients photographs by two dermatologists. Infection. Timepoint: 2, 8 weeks after the intervention. Method of measurement: Asking the patients. Shahid Beheshti University of Medical Sciences Approved 2019-04-14 Ethics committee of Skin Research Center, Shahid Beheshti University of Medical Sciences Skin Research Center,Shohada-e Tajrish Hospital, Tajrish square,Tehran Tehran Tehran Iran (Islamic Republic of)