Back to resultsFractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
Primary Purpose
Leishmaniasis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Local application pentostam
intra-lisional pentostam
fractional CO2 laser
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis
Eligibility Criteria
Inclusion Criteria:
- Objective cutaneous leishmaniasis diagnosis.
- More than one Lesion
Exclusion Criteria:
- Previous treatment
- Abnormal scarring
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
control
Arm Description
CO2 fractional laser with local application of Pentostam
Intra-lesinal Pentostam injedction
Outcomes
Primary Outcome Measures
scar appearance
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
Pain assessed by VAS
Full Information
NCT ID
NCT03009422
First Posted
December 14, 2016
Last Updated
December 30, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03009422
Brief Title
Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
CO2 fractional laser with local application of Pentostam
Arm Title
control
Arm Type
Active Comparator
Arm Description
Intra-lesinal Pentostam injedction
Intervention Type
Drug
Intervention Name(s)
Local application pentostam
Intervention Type
Drug
Intervention Name(s)
intra-lisional pentostam
Intervention Type
Device
Intervention Name(s)
fractional CO2 laser
Primary Outcome Measure Information:
Title
scar appearance
Description
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
Time Frame
At sixth month
Secondary Outcome Measure Information:
Title
Pain assessed by VAS
Time Frame
at one month, two months, and three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Objective cutaneous leishmaniasis diagnosis.
More than one Lesion
Exclusion Criteria:
Previous treatment
Abnormal scarring
12. IPD Sharing Statement
Citations:
PubMed Identifier
24170665
Citation
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.
Results Reference
background
PubMed Identifier
23012189
Citation
Al-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
Results Reference
background
PubMed Identifier
16624197
Citation
Arfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
Results Reference
background
PubMed Identifier
24845386
Citation
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.
Results Reference
background
PubMed Identifier
25348758
Citation
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.
Results Reference
background
PubMed Identifier
24664987
Citation
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.
Results Reference
background
PubMed Identifier
23294061
Citation
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.
Results Reference
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Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
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