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Leishmaniasis affecting the skin. It is the most common form of leishmaniasis. It presents with erythematous macules and papules, and nodules which may eventually ulcerate. The lesions appear in the bite site in the exposed skin areas.
Biomarker and diagnostic research for cutaneous leishmaniasis has been reported in the published literature.
No approved treatments are currently available for cutaneous leishmaniasis. An additional 4 compounds hold orphan drug designation.
While no drugs are FDA-approved specifically for cutaneous leishmaniasis, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for cutaneous leishmaniasis. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
11 clinical trials registered, 6 recruiting. Interventions under study include drug therapy, other interventions, and medical devices. Pipeline includes 1 PHASE3, 5 PHASE2, 1 PHASE1. Research is primarily sponsored by academic and government institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06798415](https://clinicaltrials.gov/study/NCT06798415) |
Data assembled from 4 of 12 sources · Last updated Sep 19, 2026, 11:55 PM UTC
Designated
Exclusivity End |
|---|
Designation Status |
|---|
Imiquimod-Ferulic Acid | Imiquimod-Ferulic Acid | Celista Pharmaceuticals LLC | 2024 | — | Designated |
(2S)-2-[(2S)-4-cyclohexyl-2-{[(2S)-1-(4-fluorobenzoyl)pyrrolidin-2-yl]formamido}butanamido]-N-(1-{[(1S)-1-{[(1S)-1-({1-[(1-{[2-({1-[(dimethylamino)methyl]cyclobutyl}carbamoyl)ethyl]carbamoyl}-1-methylethyl)carbamoyl]-1-methylethyl}carbamoyl)-3-methylbutyl | (2S)-2-[(2S)-4-cyclohexyl-2-{[(2S)-1-(4-fluorobenzoyl)pyrrolidin-2-yl]formamido}butanamido]-N-(1-{[(1S)-1-{[(1S)-1-({1-[(1-{[2-({1-[(dimethylamino)methyl]cyclobutyl}carbamoyl)ethyl]carbamoyl}-1-methylethyl)carbamoyl]-1-methylethyl}carbamoyl)-3-methylbutyl | Bacoba AG | 2021 | — | Designated |
paromomycin | paromomycin | Appili Therapeutics Inc. | 2015 | — | Designated |
sodium stibogluconate | sodium stibogluconate | Surgeon General of the US Army | 2009 | — | Withdrawn |
sodium stibogluconate is referenced in active clinical trials for cutaneous leishmaniasis (designated 2009).
Gene therapy approaches for cutaneous leishmaniasis have been reported in the published literature.
11 trials found
Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis |
PHASE2 |
Hayder Adnan Fawzi |
RECRUITING |
[NCT06746350](https://clinicaltrials.gov/study/NCT06746350) | Feasibility of Integrating Thermotherapy for Treatment of Cutaneous Leishmaniasis in Primary Health Care Setup | NA | Armauer Hansen Research Institute, Ethiopia | RECRUITING |
[NCT06797544](https://clinicaltrials.gov/study/NCT06797544) | Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis | PHASE2 | Hayder Adnan Fawzi | RECRUITING |
[NCT06798402](https://clinicaltrials.gov/study/NCT06798402) | Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate | PHASE2 | Al-Mustafa University College | RECRUITING |
[NCT00344188](https://clinicaltrials.gov/study/NCT00344188) | Diagnosis and Treatment of Leishmania Infections | — | National Institute of Allergy and Infectious Diseases (NIAID) | RECRUITING |
240 publications have been identified in PubMed for cutaneous leishmaniasis. Research spans Epidemiology / Natural History (28%), Review / Meta-Analysis (19%), and Basic Science / Preclinical (18%).
Research Type | Count | % of Total |
|---|---|---|
Disease patterns and progression | 66 | 28% |
Research summaries | 46 | 19% |
Laboratory research | 43 | 18% |
Patient case studies | 34 | 14% |
New treatment approaches | 18 | 8% |
Testing and diagnosis research | 14 | 6% |
Clinical study results | 12 | 5% |
Other research | 7 | 3% |
García Gambín Y (2026). [PMID: 42173031](https://pubmed.ncbi.nlm.nih.gov/42173031/). *Enferm Infecc Microbiol Clin (Engl Ed)*. [Diagnostic / Biomarker]
Blaizot R (2026). [PMID: 42025013](https://pubmed.ncbi.nlm.nih.gov/42025013/). *Ann Dermatol Venereol*. [Review / Meta-Analysis]
Mendivil-Tuchia de Tai S (2026). [PMID: 41108801](https://pubmed.ncbi.nlm.nih.gov/41108801/). *Diagn Microbiol Infect Dis*. [Case Report / Case Series]
de Oliveira A (2026). [PMID: 42025865](https://pubmed.ncbi.nlm.nih.gov/42025865/). *Acta Trop*. [Epidemiology / Natural History]
Al-Aqil A (2026). [PMID: 42188509](https://pubmed.ncbi.nlm.nih.gov/42188509/). *Nanomaterials (Basel)*. [Gene Therapy / Novel Therapeutics]
Aoun K (2026). [PMID: 42184356](https://pubmed.ncbi.nlm.nih.gov/42184356/). *Parasite*. [Review / Meta-Analysis]
Ortiz-Avalos J (2026). [PMID: 41269684](https://pubmed.ncbi.nlm.nih.gov/41269684/). *Vector Borne Zoonotic Dis*. [Basic Science / Preclinical]
Asadgol Z (2026). [PMID: 42050791](https://pubmed.ncbi.nlm.nih.gov/42050791/). *Int J Environ Health Res*. [Epidemiology / Natural History]
Maatallah F (2026). [PMID: 41916265](https://pubmed.ncbi.nlm.nih.gov/41916265/). *Am J Trop Med Hyg*. [Diagnostic / Biomarker]
Yasmin S (2026). [PMID: 41910007](https://pubmed.ncbi.nlm.nih.gov/41910007/). *East Mediterr Health J*. [Epidemiology / Natural History]
AI-curated news mentioning cutaneous leishmaniasis
Updated Jun 8, 2026
A recent study explores cutaneous leishmaniasis that developed from a latent dermal sinus, presenting diagnostic challenges. This research highlights the complexities in identifying this rare disease through dermoscopy.