Leishmaniasis, remains a serious health problem in many developing countries with thousands of new cases recorded annually. Novel therapies are required as existing treatment regimens are limited by their high cost, high toxicity, increased parasite resistance, patient's intolerance, and invasive means of long-duration administration. With several studies reporting the anti-leishmaniasis promise of medicinal plants, interest in plants and herbal drugs is attracting much attention worldwide. In this pilot study, we analysed extracts of Linum usitatissimum seeds (LU) to identify essential phytochemicals and test their activity against cutaneous leishmaniasis both in-vitro and in-vivo. We performed phytochemical screening of LU seeds extract as well as its in-vitro leishmanicidal and anti-amastigote assays. Water-in-oil cream containing 10% LU crude extract (10 mg/mL) was then prepared. The stability of the cream was evaluated for 28 days at 8 °C, 25 °C and 40 °C. In-vivo efficacy and safety of the cream was performed in 26 patients with cutaneous leishmaniasis who agreed to participate voluntarily in the study. The active treatment period lasted for 3 weeks, while the follow-up period was extended to 4 months. During the active study period, images of skin lesions were taken before and after treatment. Analyses of LU seeds extract confirmed the presence of terpenoids, flavonoids, tannins, alkaloids, and polyphenols. In-vitro studies showed significant activity against promastigote and intracellular amastigote forms of Leishmaniamajor. The cream was pharmaceutically stable, although some minor changes were noticed in relation to its physical characteristics. In-vivo assessment of the cream showed a 69.23% cure rate with no side effects, allergy, or irritation. We conclude that our newly developed water in oil cream containing 10% LU seeds extract could be an effective and safe topical anti-leishmanial medication for patients with CL.
Keywords: Linum usitatissimum; leishmaniasis; nutraceutical; water-in-oil cream.