Cutaneous Leishminiasis
Conditions
Brief 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.
Interventions
Intralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis.
PROCEDUREFractional CO₂ laser
Fractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis.
Sponsors
Combined military hospital Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete clinical cure | 12 weeks | Clinical Cure: Complete re-epithelialization of lesion with absence of induration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-healing Adverse events. | 12 weeks | Time-to-healing Adverse events. |
Countries
Pakistan
Contacts
CONTACTKaleem Ullan
Outcome results
None listed