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IRCT20241013063352N1 IRCT 2025-06-20 Zoonoses Research Center (Common Human and Animal Diseases), Tehran university of Medical Sciences The effect of a two-layer dressing based on nanofiber/hydrogel containing royal jelly and propolis extract on the treatment of cutaneous leishmaniasis Preparation and characterization of two-layer dressing based on nanofiber/ hydrogel containing royal jelly and propolis extract and determining its therapeutic effect on skin lesions caused by Leishmania major in human (Clinical trial – Phase 1). 2025-10-22 anticipated 44 Recruiting https://irct.ir/trial/82820 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: To randomize individuals (44 people) into 4 treatment groups, the following procedure is followed: Patients selected from Tehran and Isfahan medical centers are prepared according to the entry and exit criteria. A list of 44 eligible patients is prepared and numbered from 1 to 44. Then, using a random number table, a number between 1 and 44 is selected for each patient. The names of the 4 treatment methods are placed on 4 similar envelopes and placed in a bag. From these 4 envelopes, one envelope is extracted from the bag and assigned to the selected patient. Whenever the number of individuals in a group, which is 11 (based on their type of treatment), is complete, the envelope related to that treatment is removed and the next envelope is taken out of the bag and completed. 1 Zoonotic cutaneous leishmaniasis. Intervention 1: Control group: Standard treatment with Glucantime (injection) - Positive control: Intralesional injection in 4 areas around the wound to the extent that the wound area turns white (1-2 ml) - once a week for 3 to 5 weeks. Intervention 2: Intervention group 1: Combined dressing group including royal jelly and propolis and external coating of chitosan nanofiber (topical). The external coating consists of chitosan nanofiber with low molecular weight. Hydrogel dressing prepared with 10% gelatin and 20% concentration of propolis hydroalcoholic extract and 10% concentration of royal jelly dissolved in water are used as the internal coating of the dressing. This dressing should be changed every 24 hours. The treatment time is about one month. Intervention 3: Intervention group 2: Hydrogel dressing group with external chitosan nanofiber coating (topical): This group is similar to intervention group 1 but does not contain royal jelly and propolis hydroalcoholic extract. The hydrogel dressing is prepared with 10% gelatin and acts as the inner coating of the dressing. This dressing should also be changed every 24 hours. The treatment time is about one month. Intervention 4: Intervention group 3: Chitosan nanofiber dressing group (external coating of the studied dressing - topical) - In this group, chitosan with low molecular weight nanofibers is prepared (with an electrospinning device) and is placed on the Leishmania wound as an external coating without any other material (fixed with a bandage). The approximate treatment time is about one month. 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 Because it is likely that this project will lead to product production in the future, and the working procedure, materials studied, and product production protocol... must be confidential, it is preferable that the data be made available to other researcher in a limited manner.
public Mohsen Mahmoudi
District 6 , Pour sina St. Qods St. Enghelab St.Tehran
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 1392 mmahmoudi45@gmail.com Tehran University of Medical Sciences scientific Mohsen Mahmoudi
District 6, Pour Sina St, Qods St. Enghelab St. School of Public Health, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 1392 mmahmoudi45@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 1- Individual consent and initial agreement to continue treatment 2- Examination of the presence of Leishmaniasis in the lesion using conventional sampling methods and microscopic confirmation 3ٰٰ - Individuals between the ages of 15-45 4- Active open lesions including ulcers (for 3 to 6 months) and the size of the ulcer is less than 5 cm 5- Number of skin lesions (maximum three to four lesions per patient) 6- Iranian citizen 7- The causative agent is Leishmania major. 15 years 45 years Both Pregnant women People with immunodeficiency and underlying diseases and high-risk individuals People with old lesions (more than 5 months) or infected and recurrent People who have previously been treated with anti-leishmanial drugs Previous history of leishmaniasis Atypical forms of the disease and purulent lesions Presence of wounds or lesions in sensitive areas such as the eyelids History of allergy to honey products Users of immunosuppressive drugs Regional adenopathy L08.89 Other specified local infections of the skin and subcutaneous tissue Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: Standard treatment with Glucantime (injection) - Positive control: Intralesional injection in 4 areas around the wound to the extent that the wound area turns white (1-2 ml) - once a week for 3 to 5 weeks Intervention group 1: Combined dressing group including royal jelly and propolis and external coating of chitosan nanofiber (topical). The external coating consists of chitosan nanofiber with low molecular weight. Hydrogel dressing prepared with 10% gelatin and 20% concentration of propolis hydroalcoholic extract and 10% concentration of royal jelly dissolved in water are used as the internal coating of the dressing. This dressing should be changed every 24 hours. The treatment time is about one month. Intervention group 2: Hydrogel dressing group with external chitosan nanofiber coating (topical): This group is similar to intervention group 1 but does not contain royal jelly and propolis hydroalcoholic extract. The hydrogel dressing is prepared with 10% gelatin and acts as the inner coating of the dressing. This dressing should also be changed every 24 hours. The treatment time is about one month. Intervention group 3: Chitosan nanofiber dressing group (external coating of the studied dressing - topical) - In this group, chitosan with low molecular weight nanofibers is prepared (with an electrospinning device) and is placed on the Leishmania wound as an external coating without any other material (fixed with a bandage). The approximate treatment time is about one month. The improvement rate and reduction of skin lesions caused by Leishmania major using the designed dressing. Timepoint: Measurement of the wound and the presence of parasites in the lesion before treatment, one month, three months, and six months after treatment. Method of measurement: Measuring the dimensions of the lesion with calipers, taking a sample, and examining the presence of parasites using molecular methods (Real time PCR) at the lesion site. Possibility of causing skin sensitivity and inflammatory reactions, no scarring after the lesion heals. Timepoint: During treatment and after the lesion heals. Method of measurement: Inflammatory response test (cytokine measurement), careful observation of the site of the previous lesion for the presence or absence of scarring. Zoonoses Research Center (Common Human and Animal Diseases), Tehran university of Medical Sciences Approved 2025-04-12 Ethics Committee of Tehran University of Medical Sciences District 6,Pour Sina St. Qods St. Enghelab St. Tehran, Iran P94V+8MF. Tehran Tehran Iran (Islamic Republic of)