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Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03009422
Enrollment
20
Registered
2017-01-04
Start date
2014-11-30
Completion date
2017-06-30
Last updated
2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leishmaniasis

Brief summary

The investigators will compare the common treatment for cutaneous leishmaniasis with intra-lesional Pentostam to fractional CO2 laser with topical application of Pentostam. Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.

Detailed description

20 healthy patients diagnosed will cutaneous leishmaniasis with more than one lesion will be recruited. Half of the lesions will be treated with intra-lesional injections of Pentostam, and the other half by CO2 laser with topical application of Pentostam. Each lesion will recieve 3 treatments, one month apart between treatments. The patients will scale pain level of each treatment. Final scar appearance will be assessed by two dermatologists, without knowing what treatment was applied to each lesion.

Interventions

DRUGLocal application pentostam
DRUGintra-lisional pentostam
DEVICEfractional CO2 laser

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Objective cutaneous leishmaniasis diagnosis. * More than one Lesion

Exclusion criteria

* Previous treatment * Abnormal scarring

Design outcomes

Primary

MeasureTime frameDescription
scar appearanceAt sixth monthEach lesion will be photographed prior to treatment and at 6th month (Three months after last (3rd) treatment).Two dermatologist will asses each lesion outcome

Secondary

MeasureTime frame
Pain assessed by VASat one month, two months, and three months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026