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Comparing two methods of oral Azithromycin and cryotherapy in cutaneous leishmaniasis treatment in children

Comparing evaluation of oral Azithromycin and cryotherapy in cutaneous leishmaniasis in children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138903023862N3
Enrollment
66
Registered
2010-05-23
Start date
2007-08-21
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 oral azithromycin 10-12 mg/kg daily untill 10 days and then repeat during 3 consecutive periods according to the improvement basis. Intervention 2: Treatment with cryoth
Treatment - Drugs
Treatment - Other
Treatment with oral azithromycin 10-12 mg/kg daily untill 10 days and then repeat during 3 consecutive periods according to the improvement basis
Treatment with cryotherapy 10-20 s, until the lesion with 1 mm of its surrounding become fully infiltrated, weekly up to 8 weeks based on lesion size or complete lesion improvement

Sponsors

Research Council of Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: presence of cutaneous leishmaniasis with less than 6 months of clinical course that their disease have been approved by direct smear and stained with giemsa method or skin biopsy, age<14, a 3-month treatment free interval from the last treatment course. Exclusion criteria: pregnancy, lactating, receiving simultaneously any therapy that has antileishmaniasis effect during 2 months ago, history of significance renal, pulmonary and cardiovascular disease, sensitive to azithromycin.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Complete healing. Timepoint: For the first intervention, at the end of each month until 4 months and for second intervention at the end of 8th week and during follow up of patients in both studied group after 3 months of beginning of 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