Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study
Aim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions.Methods: This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-11-01
|
| Series: | Frontiers in Pharmacology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1280240/full |
| _version_ | 1797635086483456000 |
|---|---|
| author | Atousa Hakamifard Reza Radmehr Fatemeh Sokhanvari Fatemeh Sherkat Amirali Hariri Jaleh Varshosaz Zabihollah Shahmoradi Awat Feizi Bahareh Abtahi-Naeini Mahsa Pourmahdi-Boroujeni |
| author_facet | Atousa Hakamifard Reza Radmehr Fatemeh Sokhanvari Fatemeh Sherkat Amirali Hariri Jaleh Varshosaz Zabihollah Shahmoradi Awat Feizi Bahareh Abtahi-Naeini Mahsa Pourmahdi-Boroujeni |
| author_sort | Atousa Hakamifard |
| collection | DOAJ |
| description | Aim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions.Methods: This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were randomly assigned to two groups: the first group received liposomal clarithromycin in combination with Glucantime for 28 days, while the second group received Glucantime and a placebo. Afterward, patients were followed up at 1.5, 3, and 6 months after treatment initiation and were evaluated for recovery time, induration, and size of the lesions.Results: Sixty patients with CL lesions were divided into two separate groups with 30 members each and were examined. Within-group analysis revealed that recovery time in the clarithromycin group was 26.65 ± 5.12 days, while in the placebo group, it was 32.84 ± 24.43, which was statistically insignificant (p = 0.18). Lesion size comparison in the first and last follow-ups reduced in both groups: 7.73 ± 4.31 to 0.48 ± 0.50 in the clarithromycin group (p = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (p = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (p = 0.02). Recognizable induration reduction was observed in the clarithromycin group (2.60 ± 0.77 to 1.0 ± 0.00). No adverse effects attributable to clarithromycin were reported.Conclusion: The administration of liposomal clarithromycin in combination with systemic Glucantime had a significant beneficial effect on reducing lesion size in leishmaniasis. Further studies on larger populations are recommended.Systematic Review Registration: https://www.irct.ir/trial/46611. |
| first_indexed | 2024-03-11T12:17:17Z |
| format | Article |
| id | doaj.art-074096a0395a479c8c0cd54d2d5fbe38 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T12:17:17Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-074096a0395a479c8c0cd54d2d5fbe382023-11-07T07:17:45ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.12802401280240Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical studyAtousa Hakamifard0Reza Radmehr1Fatemeh Sokhanvari2Fatemeh Sherkat3Amirali Hariri4Jaleh Varshosaz5Zabihollah Shahmoradi6Awat Feizi7Bahareh Abtahi-Naeini8Mahsa Pourmahdi-Boroujeni9Department of Infectious Diseases, Cancer Prevention Research Center, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranDepartment of Infectious Diseases, Hormozgan University of Medical Sciences, Bandar Abbas, IranSkin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, IranFaculty of Pharmacy, Debrecen University, Debrecen, HungaryPharmaceutical Biotechnology, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, IranDrug Delivery System Research Center, Department of Pharmaceutics, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, IranDepartment of Dermatology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, IranDepartment of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, IranPediatric Dermatology Division of Department of Pediatrics, Imam Hossein Children’s Hospital, Isfahan University of Medical Sciences, Isfahan, Iran0Student Research Committee, Isfahan University of Medical Sciences, Isfahan, IranAim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions.Methods: This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were randomly assigned to two groups: the first group received liposomal clarithromycin in combination with Glucantime for 28 days, while the second group received Glucantime and a placebo. Afterward, patients were followed up at 1.5, 3, and 6 months after treatment initiation and were evaluated for recovery time, induration, and size of the lesions.Results: Sixty patients with CL lesions were divided into two separate groups with 30 members each and were examined. Within-group analysis revealed that recovery time in the clarithromycin group was 26.65 ± 5.12 days, while in the placebo group, it was 32.84 ± 24.43, which was statistically insignificant (p = 0.18). Lesion size comparison in the first and last follow-ups reduced in both groups: 7.73 ± 4.31 to 0.48 ± 0.50 in the clarithromycin group (p = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (p = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (p = 0.02). Recognizable induration reduction was observed in the clarithromycin group (2.60 ± 0.77 to 1.0 ± 0.00). No adverse effects attributable to clarithromycin were reported.Conclusion: The administration of liposomal clarithromycin in combination with systemic Glucantime had a significant beneficial effect on reducing lesion size in leishmaniasis. Further studies on larger populations are recommended.Systematic Review Registration: https://www.irct.ir/trial/46611.https://www.frontiersin.org/articles/10.3389/fphar.2023.1280240/fullleishmaniasiscutaneous leishmaniasisGlucantimeliposomal clarithromycinclarithromycin |
| spellingShingle | Atousa Hakamifard Reza Radmehr Fatemeh Sokhanvari Fatemeh Sherkat Amirali Hariri Jaleh Varshosaz Zabihollah Shahmoradi Awat Feizi Bahareh Abtahi-Naeini Mahsa Pourmahdi-Boroujeni Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study Frontiers in Pharmacology leishmaniasis cutaneous leishmaniasis Glucantime liposomal clarithromycin clarithromycin |
| title | Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study |
| title_full | Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study |
| title_fullStr | Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study |
| title_full_unstemmed | Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study |
| title_short | Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study |
| title_sort | efficacy of adjunctive topical liposomal clarithromycin on systemic glucantime in old world cutaneous leishmaniasis a pilot clinical study |
| topic | leishmaniasis cutaneous leishmaniasis Glucantime liposomal clarithromycin clarithromycin |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1280240/full |
| work_keys_str_mv | AT atousahakamifard efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT rezaradmehr efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT fatemehsokhanvari efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT fatemehsherkat efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT amiralihariri efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT jalehvarshosaz efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT zabihollahshahmoradi efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT awatfeizi efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT baharehabtahinaeini efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy AT mahsapourmahdiboroujeni efficacyofadjunctivetopicalliposomalclarithromycinonsystemicglucantimeinoldworldcutaneousleishmaniasisapilotclinicalstudy |