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IRCT20220115053715N1 IRCT 2022-01-28 Tehran University of Medical Sciences Evaluation of the effect of hyalase in treatment of keloids Comparative study of intralesional injection of hyalase, steroid and 5-fluorouracil with intralesional steroid and 5-fluorouracil in patients with keloids 2022-01-21 anticipated 16 Complete https://irct.ir/trial/61325 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: By assigning a number to each patient and using the blocked randomization site, patients are randomly assigned to one of the two groups, Blinding description: In this study, patients will not be informed which of the two treatment groups they are in. Also, two physicians who are not aware of the treatment received by each patient will evaluate the outcomes. N/A keloid. Intervention 1: Control group: Patients in the control group will receive intralesional injections of 5-fluorouracil 0.2 cc from vials of 5-fluorouracil 250mg/5ml and triamcinolone 10 mg in 3 sessions for 3 months at intervals of 3 to 4 weeks. Intervention 2: Intervention group: Patients in the intervention group will receive intralesional injections of 5-fluorouracil 0.2 cc from vials of 5-fluorouracil 250mg/5ml and triamcinolone 10 mg and hyalase 30 IU/ml in 3 sessions for 3 months at intervals of 3 to 4 weeks. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: people working in academic institutions Conditions: Scientific research Where to obtain: Dr. Amir Hooshang Ehsani; Fatemeh Sima How to obtain: The application is sent by official university email which should contain the recipient's information and the purpose of his/her request. After having verified the accuracy of the information, files would be sent. Comments:
public Fatemeh Sima
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St, Tehran city
Tehran Iran (Islamic Republic of) 1417613151 +98 21 5561 8989 f-Sima@student.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Amir Hooshang Ehsani
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St.
Tehran Iran (Islamic Republic of) 1417613151 +98 21 5561 8989 Ehsanih@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with keloid lesions based on clinical diagnosis or pathology who have not received any other treatments for at least 6 months prior to or at the same time as initiating treatment. 18 years 65 years Both Patients with coagulation disorders or hematologic disorders such as hemophilia. Patients taking blood-thinning drugs such as aspirin. L91.0 Hypertrophic scar Treatment - Drugs Treatment - Drugs Control group: Patients in the control group will receive intralesional injections of 5-fluorouracil 0.2 cc from vials of 5-fluorouracil 250mg/5ml and triamcinolone 10 mg in 3 sessions for 3 months at intervals of 3 to 4 weeks. Intervention group: Patients in the intervention group will receive intralesional injections of 5-fluorouracil 0.2 cc from vials of 5-fluorouracil 250mg/5ml and triamcinolone 10 mg and hyalase 30 IU/ml in 3 sessions for 3 months at intervals of 3 to 4 weeks. Keloid lesion diameter. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Using a ruler and Vancouver scar scale. Height of keloid lesion. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Using a ruler and Vancouver scar scale. Keloid lesion color. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observe in natural light and Vancouver scar scale. Pain. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Asking patient about pain in the lesion. Consistency. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing and touching the lesion and Vancouver scar scale. Itching. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Asking patient about presence of itching in the lesion. Skin atrophy. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion. Telangiectasia. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of the appearance of arteries as fine red lines on the skin. Hypopigmentation and hyperpigmentation. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of decrease or increase of skin pigments and Vancouver scar scale. Ulcer. Timepoint: Before treatment, end of treatment and 2 months after the end of treatment. Method of measurement: Observing the lesion in terms of presence of ulcers. Tehran University of Medical Sciences Approved 2022-01-09 Research Ethics committees of school of medicine-Tehran University of Medical Sciences Education Bldg, Tehran University of Medicine, Poursina St. Tehran Tehran Iran (Islamic Republic of)