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Comparing improvement efficacy of leishmaniasis patients with three treatment methods including combined cryotherapy and interalesional meglumine antimoniate (Glucantime) vs. cryotherapy and interalesional glucantime alone for the treatment of cutaneous leishmaniasis

Comparing efficacy of combined cryotherapy and interalesional meglumine antimoniate (Glucantime) vs. cryotherapy and interalesional meglumine antimoniate alone for the treatment of cutaneous leishmaniasis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138903063862N4
Enrollment
180
Registered
2010-05-27
Start date
2008-11-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis. Cutaneous Leishmaniasis

Interventions

Intervention 1: Treatment with cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding is completely infiltrated, and after 5 minutes, interalesional Glucantime injection into lesion, in si
Treatment - Other
Treatment - Drugs
Treatment with cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding is completely infiltrated, and after 5 minutes, interalesional Glucantime injection into lesion, in size basis, weekly
Treatment with cryotherapy 10-20 s, until the lesion and 1 mm of its surrounding is completely infiltrated, weekly up to 8 weeks
Interalesional Gluantime injection into lesion, in size basis, until the lesion is completely infiltrated and indurated, weekly up to 8 weeks

Sponsors

Research Council of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: presence of cutaneous leishmaniasis less than 6 months that their disease has been approved by direct smear and stained with Giemsa or positive skin biopsy, a 3-month treatment free interval from the last treatment course. Exclusion criteria: pregnancy, lactating, receiving simultaneously any therapy during study period that has antileishmaniasis effect during 2 months ago, history of significant renal, pulmonary and cardiovascular disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Complete healing. Timepoint: For the first time 6th and 8th weeks after treatment and for the second time in follow up visit after 3 months of beginning the study. Method of measurement: Measuring the size of induration and ulcer.

Secondary

MeasureTime frame
Side effects. Timepoint: at each follow up visit. Method of measurement: Physical exam.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadis Yousefzadeh

Research center for skin disease and cutaneous leishmaniasis

src@mums.ac.ir , hadis_yousefzadeh@yahoo.com+98 51 1841 0135

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026