Antimony plus Recombinant Human Granulocyte‐Macrophage Colony‐Stimulating Factor Applied Topically in Low Doses Enhances Healing of Cutaneous Leishmaniasis Ulcers: A Randomized, Double‐Blind, Placebo‐Controlled Study

Abstract

Cutaneous leishmaniasis (CL) requires 2-6 months to heal. In an effort to reduce this healing time, we studied topically applied granulocyte-macrophage colony-stimulating factor (GM-CSF) as an adjunct to antimonial therapy. Ten patients received antimony plus topical GM-CSF, and 10 patients received antimony plus placebo (saline). GM-CSF was diluted for topical use and was applied 3 times weekly for 3 weeks (1-2 microg/cm2/lesion). The mean +/- SD healing time was 43 +/- 14 days in the GM-CSF group and was 104+/-79 days in the placebo group (P=.043). Ten (100%) of 10 patients in the GM-CSF group healed within 60 days, compared with 5 (50%) of 10 patients in the placebo group. Two of the patients in the placebo group required retreatment with antimony. In conclusion, topically applied GM-CSF is effective in the management of CL.

Clinical and Immunological Outcome in Cutaneous Leishmaniasis Patients Treated with Pentoxifylline

“…4 Although Sb v has been the drug of choice for treatment of CL for decades, therapeutic failure has been observed in up to 40% of the patients with disease caused by L. braziliensis. 3,8 Pentoxifylline is a metilxantine used to treat vascular and chronic inflammatory diseases. 9,10 Pentoxifylline inhibits TNF-α production, 11 and the association of pentoxifylline plus antimony decreases the healing time of CL and ML, 12,13 is more effective than antimony alone, 10,11 and cures ML and CL patients refractory to Sb v therapy.…”

Efficacy of Miltefosine for the Treatment of American Cutaneous Leishmaniasis

“…Reduced sensitivity of Leishmania parasites to antimonials has also been reported. [5][6][7][8][9][10][11][12][13][14] All of these factors have driven the search for therapeutic alternatives for the treatment of leishmaniasis. 2 Various oral medications have been evaluated in the search for therapeutic alternatives to antimonials, including dapsone, 15 ketoconazol, 16,17 mefloquine, 18 allopurinol, 19 and others, 2 but none were shown to be effective.…”

Avanços no tratamento da leishmaniose tegumentar do novo mundo nos últimos dez anos: uma revisão sistemática da literatura

“…In addition, the study by Santos 34 showed that patients treated with rhGM-CSF have a lower probability of having to make repeated use of pentavalent antimonial, with reduction of the doses of antimony used and its toxicity. The topical use of rhGM-CSF in the study by Santos et al 23 reduced the costs of its use; however, the topical preparation of rhGM-CSF is not commercially available and was only produced for that investigation. The high costs of this medication make its application in clinical practice difficult; however, these studies emphasize the need for further studies on drugs that have action and efficacy similar to the rhGM-CSF, but with a reduced cost.…”

“…21 The role of rhGM-CSF as an adjuvant in the treatment of CL was evaluated in two studies. The studies by Adams et al 22 and Santos et al 23 conducted in the endemic area …”

“…, the rhGM-CSF was administered through intralesional injection, while in the study by Santos et al 23 , it was administered through topical application. The drug was well tolerated, with no reports of relevant side effects.…”