Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 3 Open-label Study of Efficacy and Safety of Miltefosine or Thermotherapy vs Glucantime for Cutaneous Leishmaniasis in Colombia.
Brief Summary: Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.

So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL.

The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients.

This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.


Options:
A: Inclusion Criteria:

* Parasitologically proven cases of CL based on positive smear and/or culture.
* Patients belonging to the National Colombian Army.
* Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
* Age 18-40 years.
* Willing to participate in the study, sign the informed consent , to go to the scheduled visits and to the follow-up visits.
* Abstain to receive any other treatment for CL during the trial and follow-up periods.
* Non purulent lesions.
* Mentally sane volunteers.
* No Leishmaniasis treatment in the six months prior to the recruitment.
* Number of lesions no more than 5

Exclusion criteria:

* None of the lesions must be close to the anal, oral and nasal mucosa, or next to the urogenital and anal canal.
* Serious systemic illnesses (as judged by the physician)
* Patients with mucosal compromise.
* Patients with diffuse Leishmaniasis ( defined as 10 or more cutaneous lesions and negative Montenegro's test)
B: Inclusion Criteria:

* Males/Females between 5 and 65 yrs
* CL diagnosis confirmed
* \>4 weeks time disease
* no prior anti-leishmanial therapy for CL
* negative pregnancy test
* informed written consent or parent consent for \<18yrs patients

Exclusion Criteria:

* \>25cm2 lesion(s)
* \>6 cutaneous lesions
* mucosal lesion
* previous exposure to Imiquimod or anti-leish treatment
* participation in another protocol within 30 days prior study
* other acute or chronic illness / medication that may interfere
* significant psychiatric illness
* anaphylaxis or severe allergic reaction to proposed drugs
* patients unlikely to cooperate
* concomitant infection
* pregnancy or breast feeding
C: Inclusion Criteria:

* Newly diagnosed (untreated) cutaneous leishmaniasis with localized lesions and a positive culture or diagnosed by polymerase chain reaction (PCR) methods or by intradermal skin testing (Montenegro test).
* Number of lesions: 1 to 3 ulcerative lesions.
* Lesion´s diameter: 1 to 5 cm.
* Disease duration: up to three months.

Exclusion Criteria:

* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary)
* Immunodeficiency or antibody to HIV
* Any non-compensated or uncontrolled condition, such as active tuberculosis, malignant disease, severe malaria, HIV, or other major infectious diseases
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months

  * Lack of suitability for the trial:
* Negative parasitology (aspirate/biopsy/PCR)or negative Montenegro test
* Any history of prior anti-leishmania therapy
* Any condition which compromises ability to comply with the study procedures

  * Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures
D: INCLUSION CRITERIA:

* Gender: Male or female
* Age: \>12 yrs of age
* Clinicla presentation: 1-2 ulcerative lesions, each \< 30 mm in largest diameter, and with a total lesion area \<900 mm2.
* Parasitological confirmation of the lesion will be made by visualization or culture of leishmania from the biopsy or aspirate of the lesion.

EXCLUSION CRITERIA:

* Previous treatment for leishmaniasis: therapy with Sb, pentamidine, amphotericin B, miltefosine, imidazoles or allopurinol in the last 3 months
* Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with IL Sb treatment.

Answer: A