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Cutaneous leishmaniasis is a common parasitic skin disease causing chronic ulcerative lesions and scarring. Intralesional meglumine antimoniate (Glucantime) is a widely used treatment; however, healing may be prolonged and cosmetic outcomes may be suboptimal. Fractional CO₂ laser therapy may enhance drug penetration, accelerate healing, and improve cosmetic results. This randomized controlled trial aims to compare the healing outcomes of intralesional Glucantime alone versus intralesional Glucantime combined with fractional CO₂ laser therapy in adult patients with cutaneous leishmaniasis treated at CMH Peshawar. A total of 150 participants will be randomized in a 1:1 ratio and followed for assessment of clinical healing, lesion size reduction, cosmetic outcomes, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional Glucantime Alone | Active Comparator | Participants will receive intralesional meglumine antimoniate (Glucantime) according to the study protocol for the treatment of cutaneous leishmaniasis. |
|
| Intralesional Glucantime + Fractional CO₂ Laser | Experimental | Participants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meglumine Antimoniate | Drug | Intralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical cure | Clinical Cure: Complete re-epithelialization of lesion with absence of induration. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-healing Adverse events. | Time-to-healing Adverse events. | 12 weeks |
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Inclusion criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaleem Ullan | Contact | +923005533753 | kalimutmani@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined military hospital peshawar | Peshawar | Khyber Pukhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25348758 | Result | 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. | |
| 20666876 | Result | Shamsi Meymandi S, Zandi S, Aghaie H, Heshmatkhah A. Efficacy of CO(2) laser for treatment of anthroponotic cutaneous leishmaniasis, compared with combination of cryotherapy and intralesional meglumine antimoniate. J Eur Acad Dermatol Venereol. 2011 May;25(5):587-91. doi: 10.1111/j.1468-3083.2010.03781.x. |
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| ID | Term |
|---|---|
| D000077485 | Meglumine Antimoniate |
| ID | Term |
|---|---|
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 |
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Clinical outcomes will be assessed by an independent blinded evaluator using standardized digital photographs. The evaluator will be unaware of treatment allocation to minimize assessment bias.
| Fractional CO₂ laser | Procedure | Fractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis. |
|
| 37233679 | Result | Sigler A, Wu J, Pfaff A, Adetunji O, Nam P, James D, Burton C, Shi H. Repeated Low-Level Blast Exposure Alters Urinary and Serum Metabolites. Metabolites. 2023 May 8;13(5):638. doi: 10.3390/metabo13050638. |
| 30281141 | Result | Artzi O, Sprecher E, Koren A, Mehrabi JN, Katz O, Hilerowich Y. Fractional Ablative CO2 Laser Followed by Topical Application of Sodium Stibogluconate for Treatment of Active Cutaneous Leishmaniasis: A Randomized Controlled Trial. Acta Derm Venereol. 2019 Jan 1;99(1):53-57. doi: 10.2340/00015555-3058. |
| 27148363 | Result | Jaffary F, Nilforoushzadeh MA, Siadat A, Haftbaradaran E, Ansari N, Ahmadi E. A Comparison between the Effects of Glucantime, Topical Trichloroacetic Acid 50% plus Glucantime, and Fractional Carbon Dioxide Laser plus Glucantime on Cutaneous Leishmaniasis Lesions. Dermatol Res Pract. 2016;2016:6462804. doi: 10.1155/2016/6462804. Epub 2016 Apr 11. |
| 15485530 | Result | Asilian A, Sharif A, Faghihi G, Enshaeieh Sh, Shariati F, Siadat AH. Evaluation of CO laser efficacy in the treatment of cutaneous leishmaniasis. Int J Dermatol. 2004 Oct;43(10):736-8. doi: 10.1111/j.1365-4632.2004.02349.x. |
| Organic Chemicals |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |