Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis
Brief Summary: "Phase III Clinical Trial for American Tegumentary Leishmaniasis: Comparison of Standard and Alternative Antimonial Dosage in Patients With American Cutaneous Leishmaniasis " has begun in October 2008 at the Laboratory of Leishmaniasis Surveillance at Evandro Chagas Clinical Research Institute (IPEC), FIOCRUZ, aiming to compare efficacy and safety of the standard recommended schedule with an alternative dosage scheme of meglumine antimoniate in the treatment of American tegumentary leishmaniasis (ATL). It is a study with blind evaluation by the doctors and the responsible for statistical analysis. Patients diagnosed with ATL, eligible for the trial are randomly allocated into one of the schemes with meglumine antimoniate and monitored before, during and after it. There is no single regimen applicable to all forms of leishmaniasis around the world. Therapeutic regimens applied to treat people living in other geographic areas result in mixed outcomes. Ideally, the most appropriate regimens should be established for each endemic area, based on its efficacy, toxicity, difficulties of administration and cost. Given the problems and limitations of the use of pentavalent antimonials (Sb5+) at 20 mg Sb5+ / kg / day, less toxic alternative regimens, i.e. 5mg Sb5+/kg/day, deserve to be better evaluated. The treatment of ATL must heal skin lesions and prevent late mucosal lesion development. The indication of high doses of Sb5+ is based on the evidence that there could be induction of resistance with use of subdoses. However, clinical studies with extended follow-up in Rio de Janeiro have suggested that regular low doses (5mg Sb5+ / kg / day) may constitute an effective scheme, achieving cure rates similar to higher doses, with lower toxicity, ease of implementation and lower cost. Published studies on efficacy and safety of alternative dosage schemes with meglumine antimoniate failed to provide conclusive results so far, for various methodological biases. The need to compare the effectiveness and safety between the standard treatment scheme with meglumine antimoniate currently recommended in Brazil for the treatment of ATL and an alternative scheme with low doses of antimony is the motive for this study in Rio de Janeiro.


Options:
A: Arm Label: Paromomycin Alone Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paromomycin Alone Cream (15% paromomycin topical cream) | Arm Label: WR 279,396; Type: ACTIVE_COMPARATOR; Interventions: Drug: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) | Intervention Type: DRUG; Name: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream); Assigned to Arm(s): WR 279,396 | Intervention Type: DRUG; Name: Paromomycin Alone Cream (15% paromomycin topical cream); Assigned to Arm(s): Paromomycin Alone Treatment
B: Arm Label: High dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Meglumine antimoniate | Arm Label: Low dose; Type: EXPERIMENTAL; Interventions: Drug: Meglumine antimoniate | Intervention Type: DRUG; Name: Meglumine antimoniate; Assigned to Arm(s): High dose, Low dose
C: Arm Label: Paromomycin Alone Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paromomycin Alone Cream (15% paromomycin topical cream) | Arm Label: WR 279,396; Type: ACTIVE_COMPARATOR; Interventions: Drug: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) | Intervention Type: DRUG; Name: WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream); Assigned to Arm(s): WR 279,396 | Intervention Type: DRUG; Name: Paromomycin Alone Cream (15% paromomycin topical cream); Assigned to Arm(s): Paromomycin Alone Treatment
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: meglumine antimoniate | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: controlled nitric oxide releasing patch | Intervention Type: DRUG; Name: controlled nitric oxide releasing patch; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: meglumine antimoniate; Assigned to Arm(s): 1

Answer: B