Evaluation of the efficacy of intralesional Glucantime plus niosomal zinc sulphate in comparison with intralesional Glucantime plus cryotherapy in the treatment of acute cutaneous leishmaniasis, a randomized clinical trial
- 1 Downloads
Current treatment modalities in cutaneous leishmaniasis have low efficacy and high toxicity as well as high rate of resistance to treatment. In this study, for the first time we decided to evaluate efficacy of intralesional Glucantime plus niosomal zinc sulphate in comparison with intralesional Glucantime plus cryotherapy in the treatment of acute cutaneous leishmaniasis. This is a case–control study on 64 patients with cutaneous leishmaniasis in Kerman-Iran. Patients were categorized in 2 groups A and B whom were treated with weekly intralesional meglumine antimonite plus twice daily niosomal topical zinc sulphate versus weekly intralesional Glucantime plus every other week cryotherapy, respectively. We assessed the efficacy of treatment modalities (as partial and complete response) and their adverse effects by measuring size of the lesions every 2 weeks up to maximum of 12 weeks and 3 months after the end of the treatment. Partial response rate was 16.6% and 12.9% in group A and B, respectively (P = 0.784). Complete response rate was 73.3% and 80.6% in group A and B, respectively (P = 0.784). Complete response rate was achieved in 4.73 ± 0.29 weeks and 4.69 ± 0.28 weeks in group A and B, respectively (P = 0.925). Partial response rate was achieved in 2.92 ± 0.23 weeks and 2.65 ± 0.18 weeks, respectively (P = 0.365). Combination of niosomal zinc sulphate with intralesional Glucantime has equal efficacy versus combination of cryotherapy plus intralesional Glucantime in the treatment of acute cutaneous leishmaniasis. So, it can be used in cases that have resistance to first-line treatments.
KeywordsNoisomes Leishmaniasis Zinc sulphate Glucantime
This investigation was extracted from an approved MD dissertation (specialty in dermatology) written by Rahim Ahmadi and financially supported by Kerman University of Medical Sciences.
MA wrote the manuscript and proposal, and acted as Corresponding author. SF involved in the conception, data screening and manuscript writing. MKH helped in data interpretation, literature search and manuscript writing. SM supervised development of work, helped to evaluate and edit the manuscript. AP provided niosomal drug and contributed in manuscript writing. RA helped in data acquisition, manuscript writing. All authors contributed in initial design, data analysis, reviewed, revised, and confirmed the manuscript.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interests
In this study, ethical permission (No. IR.KMU.AH.REC.1395.6) was granted through the Science and Ethics Committee of Kerman University of Medical Silences. All performed procedures were in accordance with the ethical standards of the Iranian institutional and/or national research committee and with the standards of 1964 Helsinki declaration.
- Aflatoonian M, Fekri A, Rahnam Z, Khalili M, Pardakhti A, Khazaeli P, Bahadini K (2017) The efficacy of combined topical niosomal dapsone gel and intralesional injection of meglumine antimoniate in comparison with intralesional meglumine antimoniate and cryotherapy in the treatment of cutaneous leishmaniasis. J Pak Assoc Dermatol 26(4):353–360Google Scholar
- Asadi M, Pardakhty A, Moshafi M, Sharifi I (2012) Preparation and in vivo administration of paromomycin niosomes in balb/c mice. Res Pharm Sci 7(5):373Google Scholar
- Farajzadeh S, Parizi MH, Haghdoost AA, Mohebbi A, Mohammadi S, Pardakhty A, Fekri AR (2016) Comparison between intralesional injection of zinc sulfate 2% solution and intralesional meglumine antimoniate in the treatment of acute old world dry type cutaneous leishmaniasis: a randomized double-blind clinical trial. J Parasit Dis 40(3):935–939CrossRefGoogle Scholar
- Firooz A, Khatami A, Khamesipour A, Nassiri-Kashani M, Behnia F, Nilforoushzadeh M, Dowlati Y (2005) Intralesional injection of 2% zinc sulfate solution in the treatment of acute old world cutaneous leishmaniasis: a randomized, double-blind, controlled clinical trial. J Drugs Dermatol 4(1):73–79PubMedGoogle Scholar
- Lerner EA, Grervelink SA (1996) Leishmaniasis. In: Ardnt KA, LeBoit PE, Robinson JK, Wintroub BU (eds) Cutaneous medicine and surgery, 1st edn. WB Saunders, Philadelphia, pp 1163–1171Google Scholar
- Lopez V, Hay RJ (2004) Parasitic worms and protozoa. In: Burns T, Breathnach S, Cox N, Griffiths C (eds) Rook’s textbook of dermatology, 7th edn. Blackwell Science, Oxford, pp 32.1–32.48Google Scholar
- Oslen RE, Berdanier CD (1994) Microminerals. In: Munson PH, Mueller RA, Breese GR (eds) Principles of pharmacology, 1st edn. Chapman & Hall, New York, pp 1002–1005Google Scholar
- Pardakhty A, Moazeni E, Varshosaz J, Hajhashemi VA, Najafabadi AR (2011) Pharmacokinetic study of niosome-loaded insulin in diabetic rats. DARU J Pharm Sci 19(6):404Google Scholar
- Sharquie KE, Noaimi AA, Sharara ZA, Saleh BA, Al-Salam WS (2017) Topical therapy of acute cutaneous leishmaniasis using zinc sulphate solution 25% versus podophyllin solution 25%. J Cosmet Dermatol Sci Appl 7(03):258Google Scholar
- Sorkhroodi FZ, Naeini AA, Ramazani AZ, Ghazvini MA, Mohebali M, Keshavarz SA (2010) Therapeutic effect of sodium selenite and zinc sulphate as supplementary with meglumine antimoniate (glucantime®) against cutaneous leishmaniasis in BALB/c mice. Iran J Parasitol 5(3):11PubMedPubMedCentralGoogle Scholar