miltefosine topical (TF 002) / JADO Tech - LARVOL DELTA

Leishmaniasis in Dhaka Medical College-experience of three years. (PubMed, Heliyon) - "Liposomal amphotericin B and 9.10% with the combination of Inj. Miltefosine. Moving forward to the elimination of leishmaniasis from Bangladesh, the study highlights the status, characteristics and treatment of the disease in the country."

Journal • Infectious Disease

Case Report: Erysipeloid Cutaneous Leishmaniasis Treated with Oral Miltefosine. (PubMed, Am J Trop Med Hyg) - "Oral miltefosine was started at a dose of 150 mg/day but had to be stopped after 20 days as the patient developed diarrhea, bipedal edema, and renal impairment. This case emphasizes an uncommon variant of CL and the role of systemic treatment with oral miltefosine and its associated adverse effects."

Clinical • Journal • Dermatology • Infectious Disease • Renal Disease

Cutaneous Leishmaniasis Treated with Miltefosine: A Case Series of 10 Paediatric Patients. (PubMed, Acta Derm Venereol) - "In conclusion, oral miltefosine may be an effective and safe treatment for Old World cutaneous leishmaniasis caused by Leishmania tropica or Leishmania major in children. However, further studies are warranted to draw a definite conclusion."

Clinical • Journal • Dermatology • Infectious Disease • Pediatrics

Cutaneous leishmaniasis successfully treated with miltefosine. (PubMed, Cutis) - "Miltefosine should be considered a first-line agent for cutaneous leishmaniasis given its efficacy, tolerability, availability, and ease of administration. Ondansetron can be prescribed concurrently."

Journal • Dermatology • Infectious Disease

Efficacy and Tolerability of Miltefosine in the Treatment of Cutaneous Leishmaniasis. (PubMed, Clin Infect Dis) - "Our data suggest that miltefosine has good but imperfect efficacy to a wide variety of Leishmania species. While side effects were common and mostly mild to moderate, some resulted in discontinuation of therapy. Due to oral administration, broad efficacy, and manageable toxicities, miltefosine is a viable alternative treatment option for CL, though cost and lack of local availability may limit its widespread use."

Clinical • Journal • Anorexia • Dermatology • Gout • Infectious Disease • Inflammatory Arthritis • Rheumatology

Cutaneous Leishmaniasis Treated with Miltefosine: A Case Series of 10 Paediatric Patients. (PubMed, Acta Derm Venereol) - "Side-effects related to the medication were minimal. In conclusion, miltefosine treatment for paediatric patients with cutaneous leishmaniasis caused by Leishmania tropica or Leishmania major is effective and safe, even in recalcitrant cases."

Clinical • Journal • Dermatology • Infectious Disease • Pediatrics

Overcoming the Challenge; In Vivo Efficacy of Miltefosine for Chronic Cutaneous Leishmaniasis. (PubMed, Acta Parasitol) - "Demonstration of both clinical and laboratory improvement in four of the five experimental animals provides strong evidence that miltefosine is an effective drug in the treatment of CCL. In the literature, no clinical or laboratory studies using miltefosine have been performed with CCL patients only."

Journal • Preclinical • Dermatology • Infectious Disease

Keratitis occurring in patients treated with miltefosine for post-kala-azar dermal leishmaniasis. (PubMed, Br J Ophthalmol) - "These observations indicate that prolonged use of miltefosine might cause keratitis that resembles infectious keratitis. Early diagnosis with discontinuation of the drug and initiation of corticosteroid therapy are the key to successful management."

Clinical • Journal • Infectious Disease • Keratitis • Ocular Inflammation • Ophthalmology • Pain

Assessing the Efficacy and Safety of Liposomal Amphotericin B and Miltefosine in Combination for Treatment of Post Kala-Azar Dermal Leishmaniasis. (PubMed, J Infect Dis) - "Liposomal amphotericin B and MIL combination for treating PKDL is efficacious and safe, with high tolerability. Furthermore, this study established the utility of minimally invasive slit aspirate method for monitoring of parasite load and assessment of cure in PKDL."

Clinical • Journal • Infectious Disease

Combination Therapy against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (Fungisome) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. (PubMed, Am J Trop Med Hyg) - "Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India."

Combination therapy • Journal • Monotherapy • Infectious Disease

Evaluation of the Ability of Miltefosine Associated with Topical GM-CSF in Modulating the Immune Response of Patients with Cutaneous Leishmaniasis. (PubMed, J Immunol Res) - "Moreover, the number of L. braziliensis in infected monocytes on day 15 as well as the percentage of infected cells was lower after 48- and 72-hour culture in cells from patients treated with miltefosine plus GM-CSF. In addition to the ability of miltefosine to kill Leishmania, the changes in the immune response caused by miltefosine and GM-CSF may increase the cure rate of CL patients using these drugs."

Clinical • Journal • Dermatology • Infectious Disease • CSF2

Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India. (PubMed, PLoS Negl Trop Dis) - "Active surveillance for PKDL and relapse, followed by timely treatment, is essential to sustain the achievements of VL elimination programs in the Indian sub-continent."

Journal • Infectious Disease

Combination, Miltefosine Monotherapy & Antimonial Therapy for Cutaneous Leishmaniasis in New World (clinicaltrials.gov) - P3; N=306; Not yet recruiting; Sponsor: Drugs for Neglected Diseases

Clinical • Combination therapy • Monotherapy • New P3 trial • Dermatology • Dermatopathology • Infectious Disease

Anti-leishmanial activity of a topical miltefosine gel in experimental models of New World cutaneous leishmaniasis. (PubMed, J Antimicrob Chemother) - "The topical 0.5% miltefosine gel formulation was efficacious and non-toxic when administered topically in NW-CL murine models. This miltefosine formulation could be an appropriate candidate for further development."

Journal • Dermatology • Dermatopathology • Immunology

[VIRTUAL] Diffuse cutaneous acanthamoebiasis in an immunodeficient patient (AAD-VMX 2020) - "Over the next 48 hours, our patient’s neurologic status rapidly deteriorated despite miltefosine, voriconazole, Bactrim, azithromycin, and topical chlorhexidine and ketoconazole. The patient died shortly after diagnosis. Autopsy revealed disseminated acanthamoeba infection involving the skin, lungs and Brain"

Clinical • CNS Disorders • Dermatology • Dermatopathology • Immunology • Keratitis • Ocular Inflammation • Ophthalmology • MRI

Outcomes of Complicated CL in Ethiopia Treated With Miltefosine (clinicaltrials.gov) - P=N/A; N=94; Completed; Sponsor: Institute of Tropical Medicine, Belgium; Recruiting ➔ Completed; N=60 ➔ 94

Clinical • Clinical data • Enrollment change • Trial completion • Dermatology • Dermatopathology

Advanced case of PKDL due to delayed treatment: A rare case report. (PubMed, PLoS Negl Trop Dis) - "Increased miltefosine tolerance in clinical isolates of Leishmania donovani has been reported and is one of the major concerns in the treatment of PKDL. Here, we report a highly ulcerated PKDL case that was successfully cured after miltefosine treatment."

Clinical • Journal

Miltefosine and GM-CSF in Cutaneous Leishmaniasis (clinicaltrials.gov) - P3; N=300; Completed; Sponsor: Hospital Universitário Professor Edgard Santos; Not yet recruiting ➔ Completed; Trial completion date: Sep 2019 ➔ Feb 2020; Trial primary completion date: Mar 2019 ➔ Aug 2019

Trial completion • Trial completion date • Trial primary completion date

Adverse ocular events on miltefosine treatment for post-kala-azar dermal leishmaniasis in India. (PubMed, Trop Doct) - "All adverse events were graded as certain using the World Health Organization-Uppsala Monitoring Centre causality assessment scale. There is need to counsel patients regarding possible adverse ocular events during MF treatment, to expand pharmacovigilance to all primary health centres in kala-azar endemic areas, and to update drug safety information considering the emerging evidence."

Adverse events • Journal

Imported cutaneous leishmaniasis: molecular investigation unveils Leishmania major in Bangladesh. (PubMed, Parasit Vectors) - "Proper monitoring and reporting of imported cases should be given careful consideration for both clinical and epidemiological reasons. Molecular tests should be performed in diagnosis to avoid dilemma, and identification of causative species should be prioritized."

Journal

Relationship between treatment regimens for visceral leishmaniasis and development of post-kala-azar dermal leishmaniasis and visceral leishmaniasis relapse: A cohort study from Bangladesh. (PubMed, PLoS Negl Trop Dis) - "Development of PKDL and VLR is related with treatment regimens for VL. SSG and MDAMB resulted in less incidence of PKDL and VLR compared to other treatment regimens. MDAMB should be considered for VL as a first step for prevention of PKDL and VLR since SSG is highly toxic and not recommended for VL."

Journal

Monitoring of parasite kinetics in Indian Post Kala Azar Dermal Leishmaniasis. (PubMed, Clin Infect Dis) - "This study aimed to monitor the efficacy of miltefosine and liposomal amphotericin B (LAmB) in PKDL based on parasite load. However, in cases treated with LAmB, the persistence of parasites suggested treatment inadequacy. This needs immediate redressal in view of the Leishmaniasis elimination programme targeted for 2020."

Journal

Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨ (clinicaltrials.gov) - P2; N=130; Completed; Sponsor: Drugs for Neglected Diseases; Active, not recruiting ➔ Completed; Trial completion date: Jun 2019 ➔ Sep 2019

Trial completion • Trial completion date

Miltefosine Induced Reduced Male Fertility Capacity after Treatment of Post Kala-azar Dermal Leishmaniasis, Bangladesh. (PubMed, Mymensingh Med J) - "Another 3 patients (10.3%) were found oligospermia (sperm count- 4.2 to 15.3 million/ml, motility- 20 to 50%, viscosity- good, pH- 6 to 9, RBC- 4 to 15/HPF, WBC- 4 to 15/HPF). The study documented some important findings in evaluating male infertility and selection of drug regimens in treating PKDL patients with miltefosine for 12 weeks."

Journal

Severe post-kala-azar dermal leishmaniasis successfully treated with miltefosine in an Ethiopian HIV patient. (PubMed, Int J Infect Dis) - "In East-Africa, the standard treatment of PKDL is with daily painful potentially toxic sodium stibogluconate injections, administered for a prolonged duration of 30-60 days. Miltefosine was efficacious, safe and well tolerated, suggesting that it can play an important role in the treatment of severe PKDL also in East-African patients. Further research is warranted."

Clinical • Journal