Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutan… (NCT07652021) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Pakistan150 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing intralesional Glucantime injections alone versus Glucantime combined with fractional CO₂ laser treatment for cutaneous leishmaniasis — can you help me understand what each of those approaches involves and whether either one might make more sense for my specific situation?
2Since this is a Phase 2 trial that hasn't started recruiting yet, what does that mean about how much is already known regarding the safety and effectiveness of combining laser treatment with Glucantime, and are there established standard treatments I should consider first?
3The trial's main goal is measuring complete clinical cure — what criteria would doctors use to define that, and how does that compare to the outcomes I might expect from treatments that are already approved and available to me right now?
4Because the trial hasn't started recruiting yet, there could be a significant wait before I could even enroll — given where my condition is right now, is it medically reasonable to wait, or should we be starting treatment sooner?
5If I were to discuss this trial with the study team once it opens, what would the practical demands look like for me — how many visits, how are the injections and laser sessions administered, and how might that fit into my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.