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IRCT20220121053776N1 IRCT 2022-02-16 Iran University of Medical Sciences Comparison of the efficacy of botulinum toxin and triamcinolone in patients with hypertrophic scars treated with PDL laser Evaluation of the efficacy, safety, satisfaction and tolerability of treatment with diluted botulinum toxin A in comparison with intralesional triamcinolone in patients undergone PDL laser for Hypertrophic erythematous scars: A blinded randomized controlled clinical trial 2022-02-20 anticipated 12 Complete https://irct.ir/trial/61537 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using simple randomization method, patients' lesions are divided into 3 groups, so that out of 36 sealed envelopes, one envelope is randomly selected for each lesion. Inside each envelope is the letter A or B or C, Blinding description: Due to the clear difference between the mentioned therapeutic interventions, it is not possible to blind the therapist and patients and the study will be performed as a single blind study. The data will be evaluated by a blind evaluator based on the images prepared from the lesions in each session and also the data analysis will be done by a blind statistical expert. 2-3 Hypertrophic erythematous scar. Intervention 1: Control group: Treatment with PDL: Before the intervention, cleaning the lesion by using normal saline impregnated gas will be done. Then, 60 minutes before laser treatment, a local anesthetic cream containing lidocaine 2.5% and prilocaine 2.5% (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied to the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using an alcohol swab. Then PDL laser using Alexandrite Deca laser device (Synchro VasQ, Deka, Florence, Italy) with a pulse of 595 nm, spot size 7 mm, single duration of half a millisecond and power of 6.5 J / cm2 with 100 shots per area A 10 × 10 cm square lesion will be applied. PDL laser will be applied in all treatment groups and in the first three sessions. Intervention 2: Intervention group 1: PDL treatment with injection of diluted botulinum toxin type A: In the second group, in addition to the PDL laser, in the first session, the injection of botulinum toxin type A of Dysport manufacturer (Speywood Pharmaceuticals Ltd., Maidenhead, UK) will be performed in diluted form immediately after laser treatment. Each vial contains Clostridium botulinum toxin type A hemoglutin complex with 125 micrograms of human albumin and 2.5 mg of lactose. Each vial has 500 units of dysport and dilution will be performed in 2.5 ml of normal saline to achieve a concentration of 200 units per ml. The toxin will then be injected at a dose of 2.5 units per cubic centimeter into the lesion, so that the total number of units injected into each lesion does not exceed 100 units. Intervention 3: Intervention group 2: PDL treatment with intralesional injection of triamcinolone: In the third group, in addition to PDL laser, in the first session, intralesional triamcinolone will be performed immediately after laser treatment. For this purpose, 40 mg / 1 triamcinolone ampoule is used (Exir Co., Tehran, Iran) which is diluted with 2% lidocaine solution (Xylopen, Exir co., Tehran, Iran) in equal volume and in a concentration of 20 Mg in 1 ml will be used. Finally, 1 ml (20 mg of triamcinolone) per 100 cm 2 of the lesion will be injected. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Najmossadat Atefi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 Atefi_roshan@yahoo.com Iran University of Medical Sciences scientific Najmossadat Atefi
Dermatology ward, Hazrat Rasool Akram hospital, Niayesh avenue, Satarkhan street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6651 7341 Atefi_roshan@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years Patients with a confirmed diagnosis of hypertrophic erythematous scars of at least 3 The size of the mentioned lesions should be at least 10 × 10 cm or have a length of at least 10 cm The patient is not pregnant or breast feeding The patient has not received any treatment for lesions such as laser, topical or injectable corticosteroids in the past two months The patient has no underlying diseases that lead to the healing process of the scar; Such as diabetes or weakened immune system The patient's cooperation in performing medical interventions and referring to all treatment sessions 18 years 50 years Both Occurrence of pregnancy during treatment or follow-up period The occurrence of allergies or any side effects to one of the therapeutic interventions that prevent further treatment Diagnosis of malignancy or systemic disease during treatment or follow-up period The appearance of bacterial or viral skin diseases during treatment or follow-up L91.0 Hypertrophic scar Treatment - Devices Treatment - Other Treatment - Other Control group: Treatment with PDL: Before the intervention, cleaning the lesion by using normal saline impregnated gas will be done. Then, 60 minutes before laser treatment, a local anesthetic cream containing lidocaine 2.5% and prilocaine 2.5% (Xyla-P, Tehran Chemie, Tehran, Iran) will be applied to the lesion. At the end of 60 minutes, the local anesthetic cream will be removed using an alcohol swab. Then PDL laser using Alexandrite Deca laser device (Synchro VasQ, Deka, Florence, Italy) with a pulse of 595 nm, spot size 7 mm, single duration of half a millisecond and power of 6.5 J / cm2 with 100 shots per area A 10 × 10 cm square lesion will be applied. PDL laser will be applied in all treatment groups and in the first three sessions. Intervention group 1: PDL treatment with injection of diluted botulinum toxin type A: In the second group, in addition to the PDL laser, in the first session, the injection of botulinum toxin type A of Dysport manufacturer (Speywood Pharmaceuticals Ltd., Maidenhead, UK) will be performed in diluted form immediately after laser treatment. Each vial contains Clostridium botulinum toxin type A hemoglutin complex with 125 micrograms of human albumin and 2.5 mg of lactose. Each vial has 500 units of dysport and dilution will be performed in 2.5 ml of normal saline to achieve a concentration of 200 units per ml. The toxin will then be injected at a dose of 2.5 units per cubic centimeter into the lesion, so that the total number of units injected into each lesion does not exceed 100 units. Intervention group 2: PDL treatment with intralesional injection of triamcinolone: In the third group, in addition to PDL laser, in the first session, intralesional triamcinolone will be performed immediately after laser treatment. For this purpose, 40 mg / 1 triamcinolone ampoule is used (Exir Co., Tehran, Iran) which is diluted with 2% lidocaine solution (Xylopen, Exir co., Tehran, Iran) in equal volume and in a concentration of 20 Mg in 1 ml will be used. Finally, 1 ml (20 mg of triamcinolone) per 100 cm 2 of the lesion will be injected. Effectiveness of treatment. Timepoint: Three months after the first treatment session. Method of measurement: By using Vancouver scar scale (VSS) scoring method. Safety. Timepoint: One, two and three months after the first treatment session. Method of measurement: Questions about possible side effects of treatment. Tolerability. Timepoint: One, two and three months after the first treatment session. Method of measurement: Question from the patient. Satisfaction. Timepoint: One, two and three months after the first treatment session. Method of measurement: Based on patient scoring. Iran University of Medical Sciences Approved 2021-11-16 Ethics committee of Iran University of medical scinces Hazrat Rasool Akram hospital, Mansoori avenue, Sattarkhan street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)