COMPARISON OF INTRALESIONAL GLUCANTIME ALONE VERSUS COMBINED WITH FRACTIONAL CO2 LASER FOR ADULT CUTANEOUS LEISHMANIASIS

June 11, 2026 updated by: Kaleem Ullah, Combined military hospital Peshawar

HEALING OUTCOMES OF INTRALESIONAL GLUCANTIME ALONE VERSUS GLUCANTIME COMBINED WITH FRACTIONAL CO₂ LASER IN ADULT 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Khyber Pukhtunkhwa
      • Peshawar, Khyber Pukhtunkhwa, Pakistan, 25000
        • Combined military hospital peshawar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: age 18-60 years Clinically diagnosed or Smear-confirmed Willing to undergo standard treatment and follow-up. -

Exclusion Criteria:Prior treatment for current lesions. Mucocutaneous leishmaniasis. Pregnancy or lactation. Severe comorbidity or immunosuppression. Lesions within 2 cm of eyelid margin or mucosal lip (safety concern for laser).

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intralesional Glucantime Alone
Participants will receive intralesional meglumine antimoniate (Glucantime) according to the study protocol for the treatment of cutaneous leishmaniasis.
Drug: Meglumine Antimoniate
Intralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis.
Experimental: Intralesional Glucantime + Fractional CO₂ Laser
Participants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis.
Drug: Meglumine Antimoniate
Intralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis.
Procedure: Fractional CO₂ laser
Fractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clinical cure
Time Frame: 12 weeks
Clinical Cure: Complete re-epithelialization of lesion with absence of induration.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-healing Adverse events.
Time Frame: 12 weeks
Time-to-healing Adverse events.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined military hospital Peshawar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHP-DERM-CL-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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