gentamicin has been researched along with Leishmaniasis, Cutaneous in 14 studies
Gentamicins: A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.
Leishmaniasis, Cutaneous: An endemic disease that is characterized by the development of single or multiple localized lesions on exposed areas of skin that typically ulcerate. The disease has been divided into Old and New World forms. Old World leishmaniasis is separated into three distinct types according to epidemiology and clinical manifestations and is caused by species of the L. tropica and L. aethiopica complexes as well as by species of the L. major genus. New World leishmaniasis, also called American leishmaniasis, occurs in South and Central America and is caused by species of the L. mexicana or L. braziliensis complexes.
Excerpt | Relevance | Reference |
---|---|---|
"Paromomycin-based topical treatments were shown to be effective in curing cutaneous leishmaniasis (CL) lesions caused by Leishmania major in Tunisia." | 2.90 | Topical paromomycin for New World cutaneous leishmaniasis. ( Adams, RC; Grogl, M; Jiménez, AI; Kreishman-Detrick, M; Lawrence, K; McCarthy, WF; Norwood, JA; Pascale, JM; Ransom, J; Scott, C; Sosa, N; Tang, D; Weina, PJ, 2019) |
" Pharmacokinetic parameters for gentamicin could not be calculated because detectable levels were rarely evident." | 2.78 | Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis. ( Grogl, M; Kopydlowski, KM; Kreishman-Deitrick, M; Lin, YJ; Llanos-Cuentas, A; Nielsen, C; Ransom, JH; Ravis, WR; Smith, KS; Smith, PL; Sosa, N, 2013) |
"Although cutaneous leishmaniasis is seen only rarely in the United States, it should be considered when diagnosing new skin lesions after travel to affected countries." | 2.58 | Cutaneous Leishmaniasis in an American Adolescent Returning From Israel. ( Ganjaei, KG; Gaur, S; Lawton, K, 2018) |
"Cutaneous leishmaniasis is presently treated with 20 days of parenteral therapy with a frequently toxic drug (antimony)." | 1.30 | Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin. ( Berman, JD; Ellis, WY; Grogl, M; Schuster, BG, 1999) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (7.14) | 18.2507 |
2000's | 4 (28.57) | 29.6817 |
2010's | 8 (57.14) | 24.3611 |
2020's | 1 (7.14) | 2.80 |
Authors | Studies |
---|---|
Mouri, O | 1 |
Melenotte, C | 1 |
Guéry, R | 1 |
Cotteret, C | 1 |
Schweitzer-Chaput, A | 1 |
Perignon, A | 1 |
Thellier, M | 1 |
Bourrat, E | 1 |
Kaguelidou, F | 1 |
Siriez, JY | 1 |
Malvy, D | 1 |
Gangneux, JP | 1 |
Duvignaud, A | 1 |
Ravel, C | 1 |
Cisternino, S | 1 |
Ransom, J | 4 |
Caumes, E | 1 |
Lortholary, O | 1 |
Grogl, M | 8 |
Buffet, P | 2 |
Ganjaei, KG | 1 |
Lawton, K | 1 |
Gaur, S | 1 |
Sosa, N | 4 |
Pascale, JM | 1 |
Jiménez, AI | 1 |
Norwood, JA | 2 |
Kreishman-Detrick, M | 1 |
Weina, PJ | 1 |
Lawrence, K | 1 |
McCarthy, WF | 3 |
Adams, RC | 2 |
Scott, C | 2 |
Tang, D | 2 |
Capitán, Z | 1 |
Nieto, J | 1 |
Nieto, M | 1 |
Calzada, J | 1 |
Paz, H | 1 |
Spadafora, C | 1 |
Kreishman-Deitrick, M | 4 |
Kopydlowski, K | 1 |
Ullman, D | 1 |
Berman, J | 2 |
Ravis, WR | 1 |
Llanos-Cuentas, A | 1 |
Kopydlowski, KM | 2 |
Nielsen, C | 1 |
Smith, KS | 2 |
Smith, PL | 3 |
Ransom, JH | 1 |
Lin, YJ | 1 |
Monge-Maillo, B | 1 |
López-Vélez, R | 1 |
Ben Salah, A | 2 |
Buffet, PA | 1 |
Morizot, G | 2 |
Ben Massoud, N | 1 |
Zâatour, A | 2 |
Ben Alaya, N | 2 |
Haj Hamida, NB | 1 |
El Ahmadi, Z | 2 |
Downs, MT | 1 |
Dellagi, K | 1 |
Daneshvar, H | 2 |
Burchmore, R | 1 |
Hagan, P | 2 |
Phillips, RS | 2 |
Costa, Sdos S | 1 |
de Assis Golim, M | 1 |
Rossi-Bergmann, B | 1 |
Costa, FT | 1 |
Giorgio, S | 1 |
Ben Messaoud, N | 1 |
Guedri, E | 1 |
Bettaieb, J | 1 |
Gharbi, A | 1 |
Belhadj Hamida, N | 1 |
Boukthir, A | 1 |
Chlif, S | 1 |
Abdelhamid, K | 1 |
Louzir, H | 1 |
Mokni, M | 1 |
Nielsen, CJ | 1 |
Ullman, DR | 1 |
Thorne, GD | 1 |
Rice, RM | 1 |
Magill, AJ | 1 |
Coombs, GH | 1 |
Asilian, A | 1 |
Faghihi, G | 1 |
Siadat, AH | 1 |
Hejazi, H | 1 |
Shahtalebi, M | 1 |
Sadeghian, G | 1 |
Mostaghim, M | 1 |
Radan, MR | 1 |
Schuster, BG | 1 |
Ellis, WY | 1 |
Berman, JD | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Double-blind, Randomized, 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[NCT01083576] | Phase 2 | 30 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
Double-blind, Randomized, Pharmacokinetics, Safety, and Efficacy Trial of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream for the Treatment of Cutaneous Leishmaniasis in Peru[NCT01032382] | Phase 2 | 30 participants (Actual) | Interventional | 2010-01-31 | Completed | ||
Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World[NCT00703924] | Phase 2 | 92 participants (Actual) | Interventional | 2003-03-31 | Completed | ||
A Pivotal, Randomized, Double-blind, Vehicle-controlled Study to Evaluate WR 279,396 and Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)[NCT00606580] | Phase 3 | 375 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
Topical Paromomycin Cream For Bolivian Cutaneous Eishmaniasis: A Controlled Study[NCT03096457] | Phase 2/Phase 3 | 80 participants (Actual) | Interventional | 2017-04-15 | Completed | ||
Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis[NCT01641796] | 0 participants | Expanded Access | No longer available | ||||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Final cure as defined by the primary outcome measure AND and cure of all other lesions by Day 168. (100% re-epithelialization of all ulcerated lesions and resolution of all other type of lesions) (NCT01083576)
Timeframe: 168 days
Intervention | Participants (Number) |
---|---|
Paromomycin Alone Treatment | 8 |
WR 279,396 | 13 |
Number of participants who had initial clinical cure (100% re-epithelialization of index lesion by Day 63) OR initial clinical improvements (> 50% re-epithelialization of index lesion followed by Day 63 by 100% re-epithelialization of the index lesion on or before Day 100), AND no relapse of index lesion. (NCT01083576)
Timeframe: 168 days
Intervention | Participants (Number) |
---|---|
Paromomycin Alone Treatment | 9 |
WR 279,396 | 13 |
Proportion of subjects with any detectable Paromomycin or Gentamicin plasma levels on a study day when blood for PK was collected (NCT01083576)
Timeframe: 20 days
Intervention | Participants (Number) | |
---|---|---|
Any detectable gentamicin | Any detectable paromomycin | |
Paromomycin Alone Treatment | 0 | 8 |
WR 279,396 | 1 | 8 |
Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults (NCT01083576)
Timeframe: Day 4 to Day 28
Intervention | ng/mL (Mean) | |||||
---|---|---|---|---|---|---|
Day 4 | Day 7 | Day 12 | Day 17 | Day 20 | Day 28 | |
Paromomycin Alone Treatment | 0 | 13.1 | 6.6 | 44.0 | 54.6 | 0 |
WR 279,396 | 17.8 | 17.6 | 26.4 | 26.3 | 31.4 | 0 |
Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children (NCT01083576)
Timeframe: Days 1 and 20
Intervention | ng/mL (Mean) | |
---|---|---|
Study Day 1 | Study Day 20 | |
Paromomycin Alone Treatment | 116.3 | 992.7 |
WR 279,396 | 98.6 | 634.2 |
Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | ng*hr/mL (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 1571 | 5603 |
WR 279,396 | 863.4 | 4740 |
Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: Days 1 and 20
Intervention | hr/ML (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 715.2 | 1725 |
WR 279,396 | 345.9 | 1380 |
Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | ng/mL (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 219.0 | 751.0 |
WR 279,396 | 121 | 561.0 |
Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | 1/ML (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 104.0 | 227 |
WR 279,396 | 61.3 | 179 |
t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | hr (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 7.03 | 5.3 |
WR 279,396 | 4.0 | 7.0 |
Tmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01083576)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | hr (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 2.7 | 2.2 |
WR 279,396 | 2.8 | 2.2 |
Blood creatinine was measured to assess possible nephrotoxicity associated with aminoglycosides (NCT01083576)
Timeframe: Day 1 and Day 20
Intervention | mg/dL (Mean) | |
---|---|---|
Study Day 1 | Study Day 20 | |
Paromomycin Alone Treatment | 0.83 | 0.77 |
WR 279,396 | 0.79 | 0.76 |
"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168." (NCT01032382)
Timeframe: Initial clinical cure by day 63 and no relapse by day 168
Intervention | participants (Number) |
---|---|
Paromomycin Alone Treatment | 11 |
WR 279,396 | 9 |
"Final clinical cure was defined as follows:~Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND,~Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168." (NCT01032382)
Timeframe: Initial clinical cure by day 63 and no relapse by day 168
Intervention | Cured ulcerated lesions (Number) |
---|---|
Paromomycin Alone Treatment | 12 |
WR 279,396 | 14 |
Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults (NCT01032382)
Timeframe: Day 4, 7, 12, 17, 20, 28
Intervention | ng/mL (Mean) | |||||
---|---|---|---|---|---|---|
Day 4 | Day 7 | Day 12 | Day 17 | Day 20 | Day 28 | |
Paromomycin Alone Treatment | 12.1 | 10.3 | 36.2 | 210.0 | 87.3 | 0 |
WR 279,396 | 37.3 | 17.9 | 78.9 | 162.0 | 128.0 | 0 |
Number of study participants who meet the criteria for clinical cure (100% re-epithelialization) at specified timepoints during the study. (NCT01032382)
Timeframe: Day 1, 4, 7, 12, 17, 20, 28, 35, 42, 49, 56, 63, 100, 168
Intervention | Lesions meeting clinical cure criteria (Number) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Day 1 | Day 4 | Day 7 | Day 12 | Day 17 | Day 20 | Day 28 | Day 35 | Day 42 | Day 49 | Day 56 | Day 63 | Day 100 | Day 168 | |
Paromomycin Alone Treatment | 0 | 0 | 0 | 0 | 0 | 1 | 5 | 8 | 10 | 10 | 11 | 11 | 12 | 11 |
WR 279,396 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 11 | 11 | 12 | 10 | 10 | 10 | 9 |
Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children (NCT01032382)
Timeframe: 0 and 4 hours on days 1 and 20
Intervention | ng/mL (Mean) | |||
---|---|---|---|---|
Day 1 hour 0 | Day 1 hour 4 | Day 20 hour 0 | Day 20 hour 4 | |
Paromomycin Alone Treatment | 6.2 | 71.2 | 93.8 | 744.0 |
WR 279,396 | 22.1 | 322.0 | 89.2 | 1030.0 |
Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01032382)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | ng*hr/mL (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 3154 | 13331 |
WR 279,396 | 1228 | 8955 |
Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01032382)
Timeframe: Days 1 and 20
Intervention | hr/ML (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 996.7 | 3335 |
WR 279,396 | 340.5 | 3155 |
Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01032382)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | ng/mL (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 511 | 1400 |
WR 279,396 | 155.0 | 882 |
Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01032382)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | 1/ML (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 185 | 368 |
WR 279,396 | 45.9 | 283 |
t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama (NCT01032382)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | hr (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 2.55 | 7.17 |
WR 279,396 | 4.51 | 6.81 |
Pharmacokinetic Parameter: Tmax (NCT01032382)
Timeframe: 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20
Intervention | hr (Mean) | |
---|---|---|
Day 1 | Day 20 | |
Paromomycin Alone Treatment | 2.25 | 4.6 |
WR 279,396 | 3 | 3 |
"Relapse is defined as enlargement of the index lesion compared to previous measurement at any time after day 50 (+ 7 days) or not demonstrating CCR by study day 180. CCR was compared using uncorrected Fisher's exact test.~Confidence intervals (95%) were constructed on the difference between the two group proportions. The log-rank test was used to compare the time to complete re-epithelialization of the index lesion without relapse. Cure of all subjects lesions was also compared using the Fisher's exact test. To adjust for baseline differences in the treatment groups, a linear model for the proportion of subjects achieving CCR was fit for each baseline variable of interest with covariates for treatment group and the baseline variable." (NCT00703924)
Timeframe: 180 days
Intervention | Participants (Count of Participants) |
---|---|
WR 279,396 | 0 |
Placebo | 3 |
Safety was evaluated on each day during daily administration of the topical products. Subjects were observed and questioned for the occurrence of solicited local side effects (eg, pain, erythema, edema) and solicited systemic side effects (eg, vertigo, tinnitus, diminished hearing). Non-solicited AE evaluations included spontaneous reports from subjects and clinical observations. (NCT00703924)
Timeframe: 180 days
Intervention | Adverse Events (Number) | ||||||
---|---|---|---|---|---|---|---|
Solicated AEs- Mild | Solicited AEs- Moderate | Solicited AEs- Severe | Non-Solicited AEs- Mild | Non-Solicited AEs- Moderate | Non-Soliciated AEs- Severe | SAEs | |
Placebo | 40 | 5 | 2 | 20 | 10 | 0 | 0 |
WR 279,396 | 49 | 11 | 2 | 13 | 10 | 0 | 1 |
100% re-epithelialization of the index lesion without having had a relapse. The log-rank test was used to compare the time to complete re-epithelialization. (NCT00703924)
Timeframe: 180 days
Intervention | Participants (Count of Participants) | |
---|---|---|
WR 279,396 | Placebo | |
Day 100 | 4 | 9 |
Day 180 (+7 Days) | 1 | 1 |
Day 20 | 10 | 20 |
Day 50 | 34 | 10 |
(NCT00606580)
Timeframe: Days 42
Intervention | Percentage of lesions (Number) |
---|---|
WR 279,396 Topical Treament | 51.7 |
Paromomycin Alone Topical Treatment | 81.6 |
Vehicle Placebo Cream | 58.1 |
(NCT00606580)
Timeframe: Days 49
Intervention | percentage of lesions (Number) |
---|---|
WR 279,396 Topical Treament | 81.4 |
Paromomycin Alone Topical Treatment | 90.4 |
Vehicle Placebo Cream | 64.9 |
(NCT00606580)
Timeframe: Days 98
Intervention | percentage of lesions (Number) |
---|---|
WR 279,396 Topical Treament | 91.5 |
Paromomycin Alone Topical Treatment | 98.9 |
Vehicle Placebo Cream | 92.2 |
For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42. (NCT00606580)
Timeframe: Day 42
Intervention | percentage of participants (Number) |
---|---|
WR 279,396 Topical Treament | 67.2 |
Paromomycin Alone Topical Treatment | 68.8 |
Vehicle Placebo Cream | 48.8 |
"Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows:~Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation.~Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98.~Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168.~Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse." (NCT00606580)
Timeframe: Day 42, 98, and 168
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 101 |
Paromomycin Alone Topical Treatment | 102 |
Vehicle Placebo Cream | 73 |
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure. (NCT00606580)
Timeframe: Day 42, 98, and 168
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 101 |
Paromomycin Alone Topical Treatment | 102 |
Vehicle Placebo Cream | 73 |
(NCT00606580)
Timeframe: Day 42
Intervention | Ulcerated lesions (Number) |
---|---|
WR 279,396 Topical Treament | 190 |
Paromomycin Alone Topical Treatment | 218 |
Vehicle Placebo Cream | 160 |
(NCT00606580)
Timeframe: Day 42
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 105 |
Paromomycin Alone Topical Treatment | 107 |
Vehicle Placebo Cream | 77 |
Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward, (NCT00606580)
Timeframe: Day 168
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 83 |
Paromomycin Alone Topical Treatment | 84 |
Vehicle Placebo Cream | 60 |
Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42 (NCT00606580)
Timeframe: Day 168
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 84 |
Paromomycin Alone Topical Treatment | 84 |
Vehicle Placebo Cream | 62 |
(NCT00606580)
Timeframe: Day 168
Intervention | participants (Number) |
---|---|
WR 279,396 Topical Treament | 4 |
Paromomycin Alone Topical Treatment | 3 |
Vehicle Placebo Cream | 2 |
(NCT00606580)
Timeframe: Days 42, 49, and 98
Intervention | percentage of participants (Number) | ||
---|---|---|---|
Day 42 | Day 49 | Day 98 | |
Paromomycin Alone Topical Treatment | 68.5 | 81.5 | 99.2 |
Vehicle Placebo Cream | 49.4 | 57.1 | 90.9 |
WR 279,396 Topical Treament | 67.2 | 72.9 | 94.3 |
1 review available for gentamicin and Leishmaniasis, Cutaneous
Article | Year |
---|---|
Cutaneous Leishmaniasis in an American Adolescent Returning From Israel.
Topics: Adolescent; Antiprotozoal Agents; Biopsy; Cellulitis; Diagnostic Errors; Female; Gentamicins; Humans | 2018 |
6 trials available for gentamicin and Leishmaniasis, Cutaneous
Article | Year |
---|---|
Topical paromomycin for New World cutaneous leishmaniasis.
Topics: Administration, Topical; Adolescent; Adult; Aged; Antiprotozoal Agents; Child; Child, Preschool; Dru | 2019 |
Randomized, double-blinded, phase 2 trial of WR 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama.
Topics: Administration, Cutaneous; Adolescent; Child; Child, Preschool; Double-Blind Method; Drug Therapy, C | 2013 |
Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis.
Topics: Adult; Child; Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2013 |
Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis.
Topics: Adult; Child; Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2013 |
Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis.
Topics: Adult; Child; Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2013 |
Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis.
Topics: Adult; Child; Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2013 |
WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study.
Topics: Adolescent; Adult; Aged; Aminoglycosides; Child; Child, Preschool; Double-Blind Method; France; Gent | 2009 |
Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.
Topics: Administration, Topical; Adolescent; Adult; Aged; Child; Child, Preschool; Drug Therapy, Combination | 2013 |
Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.
Topics: Administration, Topical; Adolescent; Adult; Aged; Child; Child, Preschool; Drug Therapy, Combination | 2013 |
Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.
Topics: Administration, Topical; Adolescent; Adult; Aged; Child; Child, Preschool; Drug Therapy, Combination | 2013 |
Topical paromomycin with or without gentamicin for cutaneous leishmaniasis.
Topics: Administration, Topical; Adolescent; Adult; Aged; Child; Child, Preschool; Drug Therapy, Combination | 2013 |
Efficacy of paromomicin and gentamicin patches in the treatment of cutaneous leishmaniasis.
Topics: Adhesives; Administration, Cutaneous; Bandages; Drug Therapy, Combination; Gentamicins; Humans; Iran | 2006 |
7 other studies available for gentamicin and Leishmaniasis, Cutaneous
Article | Year |
---|---|
Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers.
Topics: Aminoglycosides; Anti-Bacterial Agents; Antiprotozoal Agents; Gentamicins; Humans; Leishmaniasis, Cu | 2023 |
Topical paromomycin and gentamicin for new world cutaneous leishmaniasis in Panama.
Topics: Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2014 |
In response.
Topics: Female; Gentamicins; Humans; Leishmaniasis, Cutaneous; Male; Paromomycin | 2014 |
Leishmania major H-line attenuated under pressure of gentamicin, induces a Th1 response which protects susceptible BALB/c mice against infection with virulent L. major.
Topics: Animals; Antibodies, Protozoan; CD4-Positive T-Lymphocytes; Cells, Cultured; Female; Gentamicins; Hu | 2009 |
Use of in vivo and in vitro systems to select Leishmania amazonensis expressing green fluorescent protein.
Topics: Amebicides; Animals; Flow Cytometry; Gentamicins; Green Fluorescent Proteins; Host-Parasite Interact | 2011 |
Leishmania mexicana and Leishmania major: attenuation of wild-type parasites and vaccination with the attenuated lines.
Topics: Animals; Bone Marrow Cells; Culture Media; Female; Gentamicins; Leishmania donovani; Leishmania infa | 2003 |
Successful topical treatment of murine cutaneous leishmaniasis with a combination of paromomycin (Aminosidine) and gentamicin.
Topics: Administration, Topical; Animals; Antiprotozoal Agents; Benzethonium; Cricetinae; Drug Therapy, Comb | 1999 |