Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
NCT ID: NCT03009422
Last Updated: 2017-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-11-30
2017-06-30
Brief Summary
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Outcome will be final scar appearance assesd by two dermatologist and pain measurement by VAS.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
CO2 fractional laser with local application of Pentostam
Local application pentostam
fractional CO2 laser
control
Intra-lesinal Pentostam injedction
intra-lisional pentostam
Interventions
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Local application pentostam
intra-lisional pentostam
fractional CO2 laser
Eligibility Criteria
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Inclusion Criteria
* More than one Lesion
Exclusion Criteria
* Abnormal scarring
18 Years
60 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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References
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Monge-Maillo B, Lopez-Velez R. Therapeutic options for old world cutaneous leishmaniasis and new world cutaneous and mucocutaneous leishmaniasis. Drugs. 2013 Nov;73(17):1889-920. doi: 10.1007/s40265-013-0132-1.
Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
Kim DW, Hwang NH, Yoon ES, Dhong ES, Park SH. Outcomes of ablative fractional laser scar treatment. J Plast Surg Hand Surg. 2015 Apr;49(2):88-94. doi: 10.3109/2000656X.2014.919927. Epub 2014 May 21.
AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
Sklar LR, Burnett CT, Waibel JS, Moy RL, Ozog DM. Laser assisted drug delivery: a review of an evolving technology. Lasers Surg Med. 2014 Apr;46(4):249-62. doi: 10.1002/lsm.22227. Epub 2014 Mar 24.
Bloom BS, Brauer JA, Geronemus RG. Ablative fractional resurfacing in topical drug delivery: an update and outlook. Dermatol Surg. 2013 Jun;39(6):839-48. doi: 10.1111/dsu.12111. Epub 2013 Jan 7.
Other Identifiers
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TASMC-14-OA-371-CTIL
Identifier Type: -
Identifier Source: org_study_id
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