Clinical trials: Leishmaniasis, Cutaneous
Cutaneous Leishmaniasis
WR 279,396 Open Label Treatment Protocol in Tunisia
The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an open-label single site trial designed to expand our safety database and capture additional efficacy (final clinical cure rate of an index…
- Trial name
- NCT01494350
- Testing
- WR 279,396 topical cream
- Where
- Tunisia
- Volunteers
- 50 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis.
- Trial name
- NCT00703924
- Testing
- WR 279,396
- Where
- 2 sites in France, Tunisia
- Volunteers
- 92 people
- Sponsor
- U.S. Army Medical Research and Development Command
Leishmaniasis, Cutaneous
Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
- Trial name
- NCT01032382
- Testing
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream), Paromomycin Alone Cream (15% paromomycin topical cream)
- Where
- Peru
- Volunteers
- 30 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
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.
- Trial name
- NCT00884377
- Testing
- Sodium stibogluconate (Pentostam), ThermoMed
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- U.S. Army Medical Research and Development Command
Old World Cutaneous Leishmaniasis
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing) is more effective than WR279396 without occlusion for once daily treatment.
- Trial name
- NCT01536795
- Testing
- WR279,396 with Tegaderm Dressing, WR 279,396 with Gauze and Tape Dressing
- Where
- Tunisia
- Volunteers
- 48 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.
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.
- Trial name
- NCT00471705
- Testing
- Miltefosine, Thermotherapy, Glucantime®
- Where
- Colombia
- Volunteers
- 437 people
- Sponsor
- Universidad de Antioquia
Cutaneous Leishmaniasis
Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in subjects with CL in Panama.
- Trial name
- NCT01790659
- Testing
- WR 279,396, Paromomycin
- Where
- Panama
- Volunteers
- 399 people
- Sponsor
- U.S. Army Medical Research and Development Command
Skin Diseases
Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion…
- Trial name
- NCT01865032
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- U.S. Army Medical Research and Development Command
Skin Diseases, Parasitic
Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.
- Trial name
- CL Detect™ (NCT01769612)
- Testing
- No Intervention
- Where
- 2 sites in Tunisia
- Volunteers
- 168 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL).
- Trial name
- NCT01011309
- Testing
- LEISH-F2 + MPL-SE, Sodium stibogluconate
- Where
- Peru
- Volunteers
- 45 people
- Sponsor
- Access to Advanced Health Institute (AAHI)
Mucosal Leishmaniasis, Cutaneous Leishmaniasis
Miltefosine to Treat Mucocutaneous Leishmaniasis
The purpose of this Treatment Investigational New Drug application was to make miltefosine available for mucocutaneous leishmaniasis patients presenting in the United States.
- Trial name
- NCT01050907
- Testing
- Miltefosine
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Knight Therapeutics (USA) Inc
Leishmaniasis, Cutaneous
Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Panama
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
- Trial name
- NCT01083576
- Testing
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream), Paromomycin Alone Cream (15% paromomycin topical cream)
- Where
- Panama
- Volunteers
- 30 people
- Sponsor
- U.S. Army Medical Research and Development Command
Leishmaniasis, Cutaneous
Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).
- Trial name
- WRNMMC (NCT01140191)
- Testing
- WR 279,396
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA.
- Trial name
- NCT00633009
- Testing
- Leishmania tropica Skin Test Antigen (LtSTA)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Nielsen BioSciences, Inc.
Cutaneous Leishmaniasis
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries.
- Trial name
- NCT00657917
- Testing
- Paromomycin +Gentamicin topical cream
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- U.S. Army Medical Research and Development Command
Cutaneous Leishmaniasis
Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
This study will test the ability of the topical cream WR 279,396 to treat the skin lesions caused by the parasite called leishmania. WR 279,396 is an antibiotic preparation that contains paromomycin + gentamicin.
- Trial name
- NCT00606580
- Testing
- WR 279,396 topical cream, Paromomycin Alone topical cream
- Where
- Tunisia
- Volunteers
- 375 people
- Sponsor
- U.S. Army Medical Research and Development Command