Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.

Not Applicable

• Conditions: Leishmaniasis
• Interventions: Drug: Local application pentostam; Drug: intra-lisional pentostam; Device: fractional CO2 laser

• Registration Number: NCT03009422
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2016-12
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-30
• Last Update Submitted: 2016-12-30
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2017-02
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Objective cutaneous leishmaniasis diagnosis.
• More than one Lesion

Exclusion Criteria

• Previous treatment
• Abnormal scarring

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Local application pentostam	CO2 fractional laser with local application of Pentostam
Treatment	fractional CO2 laser	CO2 fractional laser with local application of Pentostam
control	intra-lisional pentostam	Intra-lesinal Pentostam injedction

Primary Outcome Measures

Name	Time	Method
scar appearance	At sixth month	Each 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 Outcome Measures

Name	Time	Method
Pain assessed by VAS	at one month, two months, and three months