Chitosan-based biocompatible dressing for treatment of recalcitrant lesions of cutaneous leishmaniasis: A pilot clinical study
Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals. Aims: The aim of this study is to evaluate the safety and efficacy of a c...
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| Published in | Indian journal of dermatology, venereology, and leprology Vol. 85; no. 6; pp. 609 - 614 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Wolters Kluwer India Pvt. Ltd
01.11.2019
Medknow Publications and Media Pvt. Ltd Scientific Scholar |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0378-6323 0973-3922 0973-3922 1998-3611 |
| DOI | 10.4103/ijdvl.IJDVL_189_18 |
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| Abstract | Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals.
Aims: The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments.
Materials and Methods: A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp.
Results: All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up.
Limitations: The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study.
Conclusion: Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis. |
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| AbstractList | Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals.
The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments.
A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp.
All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up.
The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study.
Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis. Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals. Aims: The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments. Materials and Methods: A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp. Results: All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up. Limitations: The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study. Conclusion: Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis. Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals.BACKGROUNDChitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals.The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments.AIMSThe aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments.A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp.MATERIALS AND METHODSA total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp.All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up.RESULTSAll patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up.The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study.LIMITATIONSThe lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study.Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis.CONCLUSIONOur findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis. Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals. Aims: The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments. Materials and Methods: A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp. Results: All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up. Limitations: The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study. Conclusion: Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis. |
| Audience | Academic |
| Author | Moravvej, Hamideh Dadkhahfar, Sahar Mohebali, Mehdi Mirzadeh, Hamid Abdollahimajd, Fahimeh Mahdavi, Hamid |
| Author_xml | – sequence: 1 givenname: Fahimeh surname: Abdollahimajd fullname: Abdollahimajd, Fahimeh organization: Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran – sequence: 2 givenname: Hamideh surname: Moravvej fullname: Moravvej, Hamideh organization: Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran – sequence: 3 givenname: Sahar surname: Dadkhahfar fullname: Dadkhahfar, Sahar organization: Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran – sequence: 4 givenname: Hamid surname: Mahdavi fullname: Mahdavi, Hamid organization: Department of Novel Drug Delivery Systems, Polymer Science Faculty, Iran Polymer and Petrochemical Institute, Tehran – sequence: 5 givenname: Mehdi surname: Mohebali fullname: Mohebali, Mehdi organization: Department of Medical Parasitology and Mycology, School of Public Health, Tehran University of Medical Sciences, Tehran – sequence: 6 givenname: Hamid surname: Mirzadeh fullname: Mirzadeh, Hamid organization: Department of Polymer Engineering, Amirkabir University of Technology, Tehran |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30785121$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1515_epoly_2022_0011 crossref_primary_10_1016_j_parepi_2020_e00156 crossref_primary_10_3390_pharmaceutics15122669 crossref_primary_10_3390_molecules25184123 crossref_primary_10_3390_vaccines12101179 crossref_primary_10_1016_j_micinf_2021_104910 crossref_primary_10_1016_j_mtchem_2022_101204 crossref_primary_10_1016_j_ejphar_2022_174934 crossref_primary_10_1002_mabi_202100141 crossref_primary_10_1111_dth_15682 crossref_primary_10_1007_s13346_020_00806_4 crossref_primary_10_1111_iwj_13786 |
| Cites_doi | 10.1002/14651858.CD004834.pub2 |
| ContentType | Journal Article |
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| Snippet | Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous... Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been... |
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| SubjectTerms | Adolescent Adult Aged Bandages Biocompatibility Biocompatible Materials - administration & dosage Care and treatment Child Chitin Chitosan - administration & dosage Clinical trials Cutaneous leishmaniasis Female Follow-Up Studies Humans Leishmaniasis Leishmaniasis, Cutaneous - diagnosis Leishmaniasis, Cutaneous - therapy Male Meglumine antimoniate Middle Aged Nanoparticles Parasites Parasitic diseases Patients Pilot Projects Safety and security measures Skin diseases Statistics Tropical diseases Wound healing Wound Healing - physiology Young Adult Zoonoses |
| Title | Chitosan-based biocompatible dressing for treatment of recalcitrant lesions of cutaneous leishmaniasis: A pilot clinical study |
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