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| Name | Class |
|---|---|
| Walter Reed Army Medical Center | FED |
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This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.
A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium stibogluconate intravenous | Active Comparator | 20 mg/kg/day Sodium stibogluconate intravenous |
|
| ThermoMed device | Experimental | ThermoMed device, single heat treatment at 50 degrees Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium stibogluconate (Pentostam) | Drug | intravenous 20 mg/kg/day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. | Assessment of cure is made at 2 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. |
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Inclusion Criteria:
(Inclusion criteria for randomization includes that must be Leishmania major species)
(If not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)
Exclusion Criteria:
Unable to provide informed consent
Pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone [HCG] within 48 hours of the start of infusion period)
History of hypersensitivity to pentavalent antimonials
Serious medical illness:
History of serious allergic reaction to local anesthetics
Location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage)
Presence of pacemaker and/or other implanted metallic devices
Breast feeding
Men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment
Women unwilling to avoid pregnancy for at least two months after receiving the treatment
More than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy
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| Name | Affiliation | Role |
|---|---|---|
| COL Naomi Aronson, M.D. | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20231896 | Derived | Aronson NE, Wortmann GW, Byrne WR, Howard RS, Bernstein WB, Marovich MA, Polhemus ME, Yoon IK, Hummer KA, Gasser RA Jr, Oster CN, Benson PM. A randomized controlled trial of local heat therapy versus intravenous sodium stibogluconate for the treatment of cutaneous Leishmania major infection. PLoS Negl Trop Dis. 2010 Mar 9;4(3):e628. doi: 10.1371/journal.pntd.0000628. |
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Fifty Six subjects were recruited from the Infectious Disease Clinic at Walter Reed Army Medical Center from February 2004 to March 2009. At 2 months post-treatment, subjects assessed as having failed therapy were eligible for crossover to an alternate treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With IV Sodium Stibogluconate | Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic. |
| FG001 | Treatment With Thermomed Device | Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With IV Sodium Stibogluconate | Subjects who had been randomized to the sodium stibogluconate group, received 10 days of treatment with sodium stibogluconate 20 mg/kg/day via intravenous infusions that were administered by health care personnel, generally in the WRAMC Infectious Disease Clinic or in the WRAMC infusion clinic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure | Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. | A sample size of 27 subjects per treatment group was planned based on the assumption that the cure rate in the heat treatment arm would be 73% (Navin et al., 1990), compared to a 99% cure rate in the sodium stibogluconate arm (Wortmann et al., 2002). | Posted | Count of Participants | Participants | Assessment of cure is made at 2 months after treatment |
Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Stibogluconate Intravenous | 20 mg/kg/day Sodium stibogluconate intravenous Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accute gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Severe; resolved; unrelated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lesion site blister | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naomi Aronson, Principal Investigator | Walter Reed Army Medical Center | 202-782-8691 | naronson@usuhs.mil |
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| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| ID | Term |
|---|---|
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D000967 | Antimony Sodium Gluconate |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
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| ThermoMed | Device | ThermoMed heat treatment device, one treatment |
|
| 12 months |
| Number of Participants With Solicited Adverse Events | To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events | Days 3, 7 and 10 |
| Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. | day 1 and day 10 |
| Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. | day 1 and day 10 |
| Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol. | at baseline before treatment |
| Physician Decision |
|
| BG001 |
| Treatment With Thermomed Device |
Subjects randomized to the ThermoMed arm were given one treatment session using the ThermoMed device, Model 1.8, at 50°C. A heat treatment consisted of one or more 30-second heat applications of the ThermoMed device, with the number of applications dictated by lesion size. For lesions smaller than 2 mm, a treatment consisted of only one application of the ThermoMed device. For larger lesions, a treatment involved multiple overlapping applications of the device along an imaginary line that extended across the lesion and included approximately 4 mm of apparently healthy border skin. All of a subject's cutaneous leishmaniasis lesions, up to 20, were treated |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Sodium Stibogluconate | Sodium Stibogluconate group |
| OG001 | ThermoMed Device | ThermoMed device group |
|
|
| Secondary | Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure | Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Solicited Adverse Events | To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events | Data ia showing only subjects with specified solicited symptoms on Days 3, 7 and 10. Collective count of participants for SSG is 53 and 28 for ThermoMed over all reported days. | Posted | Number | subjects showing specified symptoms | Days 3, 7 and 10 |
|
|
|
| Secondary | Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. | Populations of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10 | Posted | Mean | 95% Confidence Interval | populations of T-cells | day 1 and day 10 |
|
|
|
| Secondary | Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments | Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns. | Percent of T-cells CD3+CD8, CD19, CD16+CD56 on study days 1 and 10 | Posted | Mean | 95% Confidence Interval | % of T-cells | day 1 and day 10 |
|
|
|
| Secondary | Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial | Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol. | Posted | Count of Participants | Participants | at baseline before treatment |
|
|
|
| 0 |
| 28 |
| 5 |
| 28 |
| 28 |
| 28 |
| EG001 | ThermoMed Device | ThermoMed device, single heat treatment at 50 degrees Celsius ThermoMed: ThermoMed heat treatment device, one treatment | 0 | 28 | 2 | 28 | 28 | 28 |
|
| Osteoarthritis, left acromioclavicular joint | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate; resolved; unrelated |
|
| Injury, spine trauma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment | Severe; resolved; unrelated |
|
| Lobar pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment | Moderate; resolved; unrelated |
|
| Transanal resection of carcinoid tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment | Moderate; resolved; unrelated |
|
| Crohn's disease exacerbation | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment | Moderate; resolved; unrelated |
|
| Basal cell carcinoma, superficial | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment | Mild; resolved; unrelated |
|
|
| No blanching with pressure | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site eschar | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site keloid formation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site papules | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site plaque | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Satellite lesions | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site scaley | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site ulcer | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site verrucous | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site weeping | General disorders | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Site oedema | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Local (lesion related) |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Ventricular hypertrophy | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Site extravasation | General disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Chemical hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Amylase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Lipase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| ALT increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| AST increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| EKG T-wave abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| QRS axis abnormal | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| WBC decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Eosinophil count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Monocyte count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Platelet count decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Albumin decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Chloride increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Creatine phosphokinase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Dizziness | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | General (non-lesion related) |
|
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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Not provided
| D007239 |
| Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002264 |
| Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| Not Applicable |
|
| Clincally Cured |
|
| Not Clinically Cured |
|
| Not Evaluable |
|
| Myalgias : Day 10 |
|
| Arthralgias : Day 3 |
|
| Arthralgias : Day 7 |
|
| Arthralgias : Day 10 |
|
| Nausea : Day 3 |
|
| Nausea : Day 7 |
|
| Nausea : Day 10 |
|
| Vomiting : Day 3 |
|
| Vomiting : Day 7 |
|
| Vomiting : Day 10 |
|
| Abdominal Pain : Day 3 |
|
| Abdominal Pain : Day 7 |
|
| Abdominal Pain : Day 10 |
|
| Headache : Day 3 |
|
| Headache : Day 7 |
|
| Headache : Day 10 |
|
| Diarrhea : Day 3 |
|
| Diarrhea : Day 7 |
|
| Diarrhea : Day 10 |
|
| Rash : Day 3 |
|
| Rash : Day 7 |
|
| Rash : Day 10 |
|
| Fever : Day 3 |
|
| Fever : Day 7 |
|
| Fever : Day 10 |
|
| Fatigue : Day 3 |
|
| Fatigue : Day 7 |
|
| Fatigue : Day 10 |
|
| Chest Pain : Day 3 |
|
| Chest Pain : Day 7 |
|
| Chest Pain : Day 10 |
|
| Other : Day 3 |
|
| Other : Day 7 |
|
| Other : Day 10 |
|
| ABS CD19 (cells/uL) |
|
| ABS CD16+CD56 (cells/uL) |
|
| CD19 (%) |
|
| CD16+CD56 (%) |
|
| Culture: Not done |
|
| Culture: Unknown |
|
| Culture: Negative |
|
| Culture: Positive |
|
| Culture/Isoenzyme Analysis: L.major = Positive |
|
| Culture/Isoenzyme analysis: Unknown Leish species |
|
| Culture/Isoenzyme analysis: Not done |
|
| PCR (Genus) = Positive for Leish genus |
|
| PCR (Species) = Positive for L.major species |
|
| PCR (Species) = Unknown |
|