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IRCT20120215009014N609 IRCT 2026-05-14 Hamedan University of Medical Sciences Effect of intralesional Vitamin D versus intralesional Triamcinolone Acetonide on the treatment of keloids Effect of intralesional Vitamin D versus intralesional Triamcinolone Acetonide on the treatment of keloids: a double-blind randomized clinical trial 2026-05-31 anticipated 24 Recruiting https://irct.ir/trial/90065 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached, Blinding description: Both the medications will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. Therefore, the trial will be conducted as a double-blind study. 3 keloid. Intervention 1: Intervention group: Intralesional injection of vitamin D 300,000 units (manufactured by Caspian Pharmaceutical Co.) at a concentration of 0.2 per mL, with a maximum dose of 1 mL per lesion, using a 1 cc syringe and a 24-gauge needle, once every 3 weeks, for a maximum of 6 sessions. Intervention 2: Control Group: Intralesional injection of triamcinolone acetonide (manufactured by Exir Pharmaceutical Co.) at a concentration of 40 mg per mL, with a maximum dose of 1 mL per lesion, using a 1 cc syringe and a 24-gauge needle, once every 3 weeks, for a maximum of 6 sessions. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Dr Seyyed Mohammad Noorolahi
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 mohammad.norolahi@gmail.com Hamedan University of Medical Sciences scientific Dr. Bahareh Ebrahimi
School of Medicine, Hamadan University of Medical Sciences, Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 b.ebrahimi.4326@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years, Keloid lesion with a maximum size of 5 cm, less than 5 years old, 18 years 60 years Both Pregnancy or breastfeeding, History of prior treatment within the last 3 to 4 months, Keloid lesion on the face, Active infection at the keloid lesion site. L73.0 Acne keloid Treatment - Drugs Treatment - Drugs Intervention group: Intralesional injection of vitamin D 300,000 units (manufactured by Caspian Pharmaceutical Co.) at a concentration of 0.2 per mL, with a maximum dose of 1 mL per lesion, using a 1 cc syringe and a 24-gauge needle, once every 3 weeks, for a maximum of 6 sessions Control Group: Intralesional injection of triamcinolone acetonide (manufactured by Exir Pharmaceutical Co.) at a concentration of 40 mg per mL, with a maximum dose of 1 mL per lesion, using a 1 cc syringe and a 24-gauge needle, once every 3 weeks, for a maximum of 6 sessions. Scar severity. Timepoint: Before the intervention and three months later. Method of measurement: Using the Vancouver Scar Scale (VSS). Pain intensity. Timepoint: Before the intervention and three months later. Method of measurement: Using the Visual Analog Scale (VAS). Local complications (burning sensation, pain, itching, inflammation). Timepoint: Three months after the intervention. Method of measurement: By taking a medical history and performing a clinical examination. Hamedan University of Medical Sciences Approved 2026-04-25 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)