Combined military hospital peshawar
Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan
Not Yet Recruiting
NCT Number: NCT07652021
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Meglumine antimoniate
DrugIntralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis.
Fractional CO₂ laser
ProcedureFractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis.
Primary outcomes
-
Complete clinical cure
Time frame: 12 weeks
Clinical Cure: Complete re-epithelialization of lesion with absence of induration.
Secondary outcomes
-
Time-to-healing Adverse events.
Time frame: 12 weeks
Time-to-healing Adverse events.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Combined military hospital Peshawar
Other Gov
Registry information
Official study title
A Randomized Controlled Trial Comparing Healing Outcomes of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 16, 2026
- Registry last updated
- Jun 18, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.