Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Leishmaniasis

Treatments: Drug: intra-lisional pentostam; Drug: Local application pentostam; Device: fractional CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03009422

TASMC-14-OA-371-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Objective cutaneous leishmaniasis diagnosis.
• More than one Lesion

Exclusion criteria

• Previous treatment
• Abnormal scarring

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Treatment

Experimental group

Description:

CO2 fractional laser with local application of Pentostam

Treatment:

Drug: Local application pentostam

Device: fractional CO2 laser

control

Active Comparator group

Description:

Intra-lesinal Pentostam injedction

Treatment:

Drug: intra-lisional pentostam