Effect of intralesional Vitamin D versus intralesional Triamcinolone Acetonide on the treatment of keloids: a double-blind randomized clinical trial

To assess the effect of intralesional Vitamin D versus intralesional Triamcinolone Acetonide on the treatment of keloids

This is a Phase III double-blind randomized clinical trial with a control group with parallel groups, in which 24 eligible patients will be randomly assigned to the intervention and control groups using block randomization.

This study will be conducted at the Sina Hospital in Hamadan city, involving 24 eligible patients with keloids. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double -blinded.

Inclusion criteria: Age 18 to 60 years, Keloid lesion with a maximum size of 5 cm, less than 5 years old, Exclusion Criteria: 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.

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.

Primary outcome: Scar severity; Pain intensity Secondary outcome: Local complications (burning sensation, pain, itching, inflammation)

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.

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.