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Not Yet Recruiting NCT07652021

Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis

Conditions: Cutaneous Leishminiasis

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 150
Sponsor: Combined military hospital Peshawar

Location: Combined military hospital peshawar Peshawar Khyber Pukhtunkhwa

Summary

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.

Eligibility Criteria

Inclusion criteria * Age ≥18 years and ≤60 years. * Clinically diagnosed and/or smear-confirmed cutaneous leishmaniasis. * Presence of at least one measurable cutaneous lesion suitable for treatment. * Willing and able to provide written informed consent. * Willing to undergo study treatment and comply with scheduled follow-up visits. Exclusion Criteria * Previous treatment for the current lesion(s). * Mucocutaneous or visceral leishmaniasis. * Pregnancy or lactation. * Severe systemic illness or immunosuppression. * Known hypersensitivity or contraindication to study interventions. * Lesions located within 2 cm of the eyelid margin or mucosal lip (laser safety concern). * Inability or unwillingness to comply with study procedures or follow-up.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07652021). StuddyBuddy aggregates publicly available trial information.