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IRCT20220902055857N1 IRCT 2022-09-07 Ahvaz University of Medical Sciences Effect of intralesional vitamin D in treatment of keloid Comparison of intralesional vitamin D with intralesional triamcinolone acetonide in the treatment of keloids 2022-09-23 anticipated 26 Complete https://irct.ir/trial/65662 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple random assignment method is that for patients with one lesion, odd numbers are given to the intervention group (new treatment) and even numbers are given to the control group (common treatment).Then, according to the number of the studied sample, the relevant numbers are extracted using the computer, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient in The study is registered and entered into the study, the envelope related to patient number 1 and envelope number 2 will be given to the second patient. In the same way, this work will continue until the end of the sample size of the study. In order to maintain randomization, the person who prepares the envelopes with The person who registers the patients and provides the envelopes to the patients should be different. For patients who have two lesions, one envelope is given for the right side lesions and the highest lesion. 3 Keloid. Intervention 1: Intervention group: Intralesional injection of vitamin D ampoule from Caspian Pharmaceutical Company will be prescribed to patients. Vitamin D ampoule 300,000 units will be injected at a dose of 0.2 ml per 1 cm of the lesion. A maximum of one milliliter of vitamin D will be injected into each lesion. The intervals of the treatment sessions are once every 3 weeks and the treatment continues until the scar flattens; an average of 6 sessions is considered the duration of the patient's treatment. Intervention 2: Control group: Intralesional injection of triamcinolone from EXIR with a concentration of 40 mg per milliliter is used in a maximum of six sessions, a maximum of one milliliter is injected in each lesion, the injection intervals in this treatment are also done once every 3 weeks. 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 Sedigheh Sananzadeh
No. 8; Row 1013; Valiasr St
Abadan Iran (Islamic Republic of) 6315963439 +98 61 3311 0000 sananzadeh.s@ajums.ac.ir Ahvaz University of Medical Sciences scientific Nader Pazyar
Imam khomeini hospital, Dermatology clinic, Azadegan Ave
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3292 1873 Dr.Pazyar@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Willingness and cooperation to participate in the study All patients with two or more keloids The duration of lesions should be less than 5 years and they have not been treated yet keloids with different sizes up to 5 cm and in different parts of the body 18 years 60 years Both keloid on face active infection in or near the keloid site pregnant or lactating patients patients with underlying diseases such as diabetes, mental illness, cancer and heart disease L91.0 Hypertrophic scar Treatment - Drugs Treatment - Drugs Intervention group: Intralesional injection of vitamin D ampoule from Caspian Pharmaceutical Company will be prescribed to patients. Vitamin D ampoule 300,000 units will be injected at a dose of 0.2 ml per 1 cm of the lesion. A maximum of one milliliter of vitamin D will be injected into each lesion. The intervals of the treatment sessions are once every 3 weeks and the treatment continues until the scar flattens; an average of 6 sessions is considered the duration of the patient's treatment. Control group: Intralesional injection of triamcinolone from EXIR with a concentration of 40 mg per milliliter is used in a maximum of six sessions, a maximum of one milliliter is injected in each lesion, the injection intervals in this treatment are also done once every 3 weeks. Keloid score in the Vancouver Scar scale. Timepoint: Vancouver scar scale upon arrival, 3, 6, 9, 12, 15 weeks after each injection session until the lesion is completely flattened or up to 6 sessions. Method of measurement: Vancouver scar scale. Patient satisfaction from treatment. Timepoint: End of treatment. Method of measurement: Visual Analogue Scale. Ahvaz University of Medical Sciences Approved 2022-06-21 Ethics Committee of JundiShapur Ahvaz University of Medical Sciences Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences; Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)