Cutaneous LeishminiasisPhase 2NCT07652021
Comparison of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
A Phase 2 study testing Meglumine Antimoniate and Fractional CO₂ laser in people with Cutaneous Leishminiasis, run by Combined military hospital Peshawar at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cutaneous Leishminiasis
- What is being tested?
- Meglumine Antimoniate and Fractional CO₂ laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Combined military hospital peshawar
Peshawar, Khyber Pukhtunkhwa, 25000
Lt col dr umair Riaz, +923335641418, Umairdr82@gmail.com
About this study
Official title: A Randomized Controlled Trial Comparing Healing Outcomes 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.
- Conditions
- Cutaneous Leishminiasis
- Being tested
- Meglumine Antimoniate, Fractional CO₂ laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meglumine AntimoniateDrug
Intralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis.
Fractional CO₂ laserProcedure or surgery
Fractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Glucantime Alone | Active comparator | Participants will receive intralesional meglumine antimoniate (Glucantime) according to the study protocol for the treatment of cutaneous leishmaniasis. Receives: Drug: Meglumine Antimoniate |
| Intralesional Glucantime + Fractional CO₂ Laser | Experimental | Participants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis. Receives: Drug: Meglumine Antimoniate; Procedure: Fractional CO₂ laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clinical cure
Clinical Cure: Complete re-epithelialization of lesion with absence of induration.
Measured: 12 weeks
Secondary outcomes (1)
Time-to-healing Adverse events.
Time-to-healing Adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cutaneous LeishminiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Combined military hospital Peshawar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kaleem Ullah, Combined military hospital Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652021
- Sponsor's protocol ID
- CMHP-DERM-CL-2026-001
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
PubMed 25348758Shamsi Meymandi S, Zandi S, Aghaie H, Heshmatkhah A. Efficacy of CO(2) laser for treatment of anthroponotic cutaneous leishmaniasis, compared with combination of cryotherapy and intralesional meglumine antimoniate. J Eur Acad Dermatol Venereol. 2011 May;25(5):587-91. doi: 10.1111/j.1468-3083.2010.03781.x.
PubMed 20666876Sigler A, Wu J, Pfaff A, Adetunji O, Nam P, James D, Burton C, Shi H. Repeated Low-Level Blast Exposure Alters Urinary and Serum Metabolites. Metabolites. 2023 May 8;13(5):638. doi: 10.3390/metabo13050638.
PubMed 37233679Artzi O, Sprecher E, Koren A, Mehrabi JN, Katz O, Hilerowich Y. Fractional Ablative CO2 Laser Followed by Topical Application of Sodium Stibogluconate for Treatment of Active Cutaneous Leishmaniasis: A Randomized Controlled Trial. Acta Derm Venereol. 2019 Jan 1;99(1):53-57. doi: 10.2340/00015555-3058.
PubMed 30281141Jaffary F, Nilforoushzadeh MA, Siadat A, Haftbaradaran E, Ansari N, Ahmadi E. A Comparison between the Effects of Glucantime, Topical Trichloroacetic Acid 50% plus Glucantime, and Fractional Carbon Dioxide Laser plus Glucantime on Cutaneous Leishmaniasis Lesions. Dermatol Res Pract. 2016;2016:6462804. doi: 10.1155/2016/6462804. Epub 2016 Apr 11.
PubMed 27148363Asilian A, Sharif A, Faghihi G, Enshaeieh Sh, Shariati F, Siadat AH. Evaluation of CO laser efficacy in the treatment of cutaneous leishmaniasis. Int J Dermatol. 2004 Oct;43(10):736-8. doi: 10.1111/j.1365-4632.2004.02349.x.
PubMed 15485530
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Healing Outcomes of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
- ClinicalTrials.gov ID
- NCT07652021
- Acronym / sponsor ID
- CMHP-DERM-CL-2026-001
- Conditions
- Cutaneous Leishminiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Combined military hospital PeshawarOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Glucantime Alone | Active comparator | Drug: Meglumine AntimoniateParticipants will receive intralesional meglumine antimoniate (Glucantime) according to the study protocol for the treatment of cutaneous leishmaniasis. |
| Intralesional Glucantime + Fractional CO₂ Laser | Experimental | Drug: Meglumine Antimoniate, Procedure: Fractional CO₂ laserParticipants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meglumine AntimoniateIntralesional meglumine antimoniate (Glucantime) administered according to the study protocol for treatment of cutaneous leishmaniasis. | Drug | Intralesional Glucantime + Fractional CO₂ Laser, Intralesional Glucantime Alone |
| Fractional CO₂ laserFractional carbon dioxide laser therapy administered according to the study protocol as an adjunct to intralesional meglumine antimoniate treatment for cutaneous leishmaniasis. | Procedure or surgery | Intralesional Glucantime + Fractional CO₂ Laser |
Primary outcome
Complete clinical cure
Time frame: 12 weeks
Clinical Cure: Complete re-epithelialization of lesion with absence of induration.
1 secondary outcome
Time-to-healing Adverse events.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 25348758AlGhamdi K, Khurrum H. Successful treatment of atrophic facial leishmaniasis scars by co2 fractional laser. J Cutan Med Surg. 2014 Nov;18(6):379-84. doi: 10.2310/7750.2014.13175.
- Results publication: PubMed 20666876Shamsi Meymandi S, Zandi S, Aghaie H, Heshmatkhah A. Efficacy of CO(2) laser for treatment of anthroponotic cutaneous leishmaniasis, compared with combination of cryotherapy and intralesional meglumine antimoniate. J Eur Acad Dermatol Venereol. 2011 May;25(5):587-91. doi: 10.1111/j.1468-3083.2010.03781.x.
- Results publication: PubMed 37233679Sigler A, Wu J, Pfaff A, Adetunji O, Nam P, James D, Burton C, Shi H. Repeated Low-Level Blast Exposure Alters Urinary and Serum Metabolites. Metabolites. 2023 May 8;13(5):638. doi: 10.3390/metabo13050638.
- Results publication: PubMed 30281141Artzi O, Sprecher E, Koren A, Mehrabi JN, Katz O, Hilerowich Y. Fractional Ablative CO2 Laser Followed by Topical Application of Sodium Stibogluconate for Treatment of Active Cutaneous Leishmaniasis: A Randomized Controlled Trial. Acta Derm Venereol. 2019 Jan 1;99(1):53-57. doi: 10.2340/00015555-3058.
- Results publication: PubMed 27148363Jaffary F, Nilforoushzadeh MA, Siadat A, Haftbaradaran E, Ansari N, Ahmadi E. A Comparison between the Effects of Glucantime, Topical Trichloroacetic Acid 50% plus Glucantime, and Fractional Carbon Dioxide Laser plus Glucantime on Cutaneous Leishmaniasis Lesions. Dermatol Res Pract. 2016;2016:6462804. doi: 10.1155/2016/6462804. Epub 2016 Apr 11.
- Results publication: PubMed 15485530Asilian A, Sharif A, Faghihi G, Enshaeieh Sh, Shariati F, Siadat AH. Evaluation of CO laser efficacy in the treatment of cutaneous leishmaniasis. Int J Dermatol. 2004 Oct;43(10):736-8. doi: 10.1111/j.1365-4632.2004.02349.x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meglumine Antimoniate and Fractional CO₂ laser in people with Cutaneous Leishminiasis, run by Combined military hospital Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaleem Ullan (+923005533753, kalimutmani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clinical cure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07652021, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.