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IRCT20140624018210N10 IRCT 2020-12-13 Iran University of Medical Sciences Formulation and manufacturing of corticosteroid free ointment for treatment of eczema Evaluating the efficacy of corticosteroid free ointment in the treatment of patient with eczema 2020-12-01 anticipated 75 Complete https://irct.ir/trial/52718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization is a commonly used technique in clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms. This method increases the probability that each arm will contain an equal number of individuals by sequencing participant assignments by block.The randomization unit is individual and randomization's tool is a statistical software.randomization is a simple method using statistical software SPSS version 22.Both drugs are packaged in the same container of 100 grams. The randomization list is prepared by a statistical consultant and a number is given to each medicine container. The participant and the main researcher and the doctor who is responsible for following up the patient and evaluating the outcome of the drug use are not aware of the nature of the drug used, Blinding description: In this study, the outcome assessor and participants have been blinded. The outcome assessor is people who are responsible for gathering data and outcome variables and does not know which participant received which drug. 3 eczema. Intervention 1: Intervention group: A group treated with formulated ointment containing active ingredients . Formulation:1)First, dissolve 8 grams of carbomer in one and a half liters of water and then bring the dissolved carbomer to a temperature of 70 degrees Celsius.2)In the next step, sterile acetyl alcohol + acetyl alcohol + liquid paraffin + GMS 32 g + stearate 20, + dimethicone + Vaseline is added and placed on the heater to dissolve completely.3)The active ingredients are weighed on the scales and added to the container, respectively. The active ingredients: omega 6 (linoleic acid) + zinc oxide + biotin + vitamin B6 + vitamin B12 + menthol were added one gram. It should be noted that the active ingredients are micronized4)Then items 1 and 2 were mixed together and homogenized with a homogenizer and finally triethanolamine was added.5)Methyl isothiosolonium preservative was added for 400C. all patients have signatured informed consent documents and were given a complete explanation about the sudy procedures .after the first visit and examination, patients would start the treatment period and after a month of treatment would be re-examined for treatment efficacy and followup checkups. treatment dosage is variable from 2 to 10 gr and should be administred on the lesion two times per day. oinment administration procedure is dependent on lesion size and each patient should use the oinment based on their lesion size in a manner that the surface of lesion shoud be fully covered with the oinment. The place of cream formulation has been done in Oud Kala factory (Alborz province, Baharestan town, Golestan 10th, Oud Kala factory (health-pharmaceutical products factory)). Intervention 2: Intervention group: A group that uses standard ointments such as eucerin. Intervention 3: Control group: A group treated with ointments without active ingredients. No - There is not a plan to make this available Justification or reason for not sharing IPD is No - There is not a plan to make this available
public Dr. Nuredin Bakhtiari
Tehran - Shahid Babaei Highway (west to east) - Hakimiyeh exit - Shahid Sadoughi St. - Shahid Abbaspour Boulevard - Islamic Azad University North Tehran Branch
Tehran Iran (Islamic Republic of) 1493889878 +98 21 4476 4532 nuredin1480@gmail.com Islamic Azad University scientific Dr Elham Behrangi
Dermatology Department,Rasool-Akram-Hospital,Satarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6650 2040 behrangi.e@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Only patients with active eczema lesions are included in this study. no limit no limit Both Patients with very large (severe) lesions Patients with a history of skin diseases other than eczema L20.89 Other atopic dermatitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: A group treated with formulated ointment containing active ingredients . Formulation:1)First, dissolve 8 grams of carbomer in one and a half liters of water and then bring the dissolved carbomer to a temperature of 70 degrees Celsius.2)In the next step, sterile acetyl alcohol + acetyl alcohol + liquid paraffin + GMS 32 g + stearate 20, + dimethicone + Vaseline is added and placed on the heater to dissolve completely.3)The active ingredients are weighed on the scales and added to the container, respectively. The active ingredients: omega 6 (linoleic acid) + zinc oxide + biotin + vitamin B6 + vitamin B12 + menthol were added one gram. It should be noted that the active ingredients are micronized4)Then items 1 and 2 were mixed together and homogenized with a homogenizer and finally triethanolamine was added.5)Methyl isothiosolonium preservative was added for 400C. all patients have signatured informed consent documents and were given a complete explanation about the sudy procedures .after the first visit and examination, patients would start the treatment period and after a month of treatment would be re-examined for treatment efficacy and followup checkups. treatment dosage is variable from 2 to 10 gr and should be administred on the lesion two times per day. oinment administration procedure is dependent on lesion size and each patient should use the oinment based on their lesion size in a manner that the surface of lesion shoud be fully covered with the oinment. The place of cream formulation has been done in Oud Kala factory (Alborz province, Baharestan town, Golestan 10th, Oud Kala factory (health-pharmaceutical products factory)) Intervention group: A group that uses standard ointments such as eucerin Control group: A group treated with ointments without active ingredients 1) itching 2) redness 3) burning 4) inflammation 5) wound healing. Timepoint: End of the treatment period. Method of measurement: Clinical examination. Iran University of Medical Sciences Approved 2020-11-30 Ethic committee of Iran University Of Medical sience Iran university -Hemat Highway Tehran Tehran Iran (Islamic Republic of)