Fractional CO2 Laser With Topical Pentostam Treatment for Cutaneous Leishmaniasis.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJanuary 4, 2017
December 1, 2016
2.3 years
December 14, 2016
December 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
At sixth month
Secondary Outcomes (1)
Pain assessed by VAS
at one month, two months, and three months
Study Arms (2)
Treatment
EXPERIMENTALCO2 fractional laser with local application of Pentostam
control
ACTIVE COMPARATORIntra-lesinal Pentostam injedction
Interventions
Eligibility Criteria
You may qualify if:
- Objective cutaneous leishmaniasis diagnosis.
- More than one Lesion
You may not qualify if:
- Previous treatment
- Abnormal scarring
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
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.
PMID: 24170665BACKGROUNDAl-Natour SH. Update in the treatment of cutaneous leishmaniasis. J Family Community Med. 2009 May;16(2):41-7.
PMID: 23012189BACKGROUNDArfan-ul-Bari, Simeen-ber-Rahman. Scar leishmaniasis. J Coll Physicians Surg Pak. 2006 Apr;16(4):294-5.
PMID: 16624197BACKGROUNDKim 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.
PMID: 24845386BACKGROUNDAlGhamdi 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.
PMID: 25348758BACKGROUNDSklar 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.
PMID: 24664987BACKGROUNDBloom 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.
PMID: 23294061BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2016
First Posted
January 4, 2017
Study Start
November 1, 2014
Primary Completion
February 1, 2017
Study Completion
June 1, 2017
Last Updated
January 4, 2017
Record last verified: 2016-12