Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.

NCT ID: NCT03009422

Last Updated: 2017-01-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Leishmaniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

CO2 fractional laser with local application of Pentostam

Group Type EXPERIMENTAL

Local application pentostam

Intervention Type DRUG

fractional CO2 laser

Intervention Type DEVICE

control

Intra-lesinal Pentostam injedction

Group Type ACTIVE_COMPARATOR

intra-lisional pentostam

Intervention Type DRUG

Interventions

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Local application pentostam

Intervention Type DRUG

intra-lisional pentostam

Intervention Type DRUG

fractional CO2 laser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Objective cutaneous leishmaniasis diagnosis.
* More than one Lesion

Exclusion Criteria

* Previous treatment
* Abnormal scarring
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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.

Reference Type BACKGROUND
PMID: 24170665 (View on PubMed)

Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.

Reference Type BACKGROUND
PMID: 23012189 (View on PubMed)

Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.

Reference Type BACKGROUND
PMID: 16624197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24845386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25348758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24664987 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23294061 (View on PubMed)

Other Identifiers

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TASMC-14-OA-371-CTIL

Identifier Type: -

Identifier Source: org_study_id

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