Target Product Profile for Cutaneous Leishmaniasis
A target product profile (TPP) for cutaneous leishmaniasis (CL) has been developed in consultations with cutaneous leishmaniasis experts, researchers and clinicians from both Old and New World. The TPP is being been reviewed and updated on regular bases and has been approved by the R&D team and SAC.
The main goal of the cutaneous leishmaniasis program at DNDi is to achieve short duration, safe, non-invasive, efficacious, affordable and field-friendly treatments for cutaneous leishmaniasis caused by L.tropica and L. braziliensis.
|Species dependent treatment response||One treatment for All species of Leishmania||L. tropica or L. braziliensis|
|Safety monitoring requirement
||None||Primary Health Care (minimal contact).
No major safety concerns.
Common Terminology Criteria for AE1
All AR’s < grade 1
|Well tolerated in >95% of patients treated.
Systemic AR > grade 2 in <5%.
Local AR ≤ grade 2 in <30%.
No treatment induced mortality.
|Contraindications||None||Can be assessed at PHC level.|
|Pregnancy||Safe in pregnancy and lactation||Category B2|
|Complete clinical cure at 3 months from treatment onset
||>95% patients||60% for L. tropica
70% for L. braziliensis
|Improved scar formation||Minimal scar||No worse than natural healing|
|Prevention of relapse and recidivans||No relapse or recidivans/ML||<5% rate of relapse or recidivans/ML at 1 year|
|Parasitological endpoint requirement||None||None|
|Drug / Treatment schedule
|Route of administration
||Topical / oral||Non-parenteral or few doses if parenteral|
||14 days||28 days|
|Oral||< 7 days||Oral: bid for 28 days|
|Age||No restrictions||> 9 months of age|
|Gender||No restrictions||No restrictions|
|Use in Pregnancy||Yes||No|
|Efficacy in immuno-compromised patients||Yes||No|
|Stability||No cold chain,
at least 3 years at 37ºC
|2 years at 4-8ºC|
|Cost of products / procedures per treatment||US$5||US$50|
1 National Cancer Institute. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events v3.0.
2 No signs of risk in animal studies, but no adequate studies in humans.