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Comparison between two groups in the treatment of cutaneous leishmaniasis

Comparison between the efficacy of intralesional placebo and nitric oxide releasing patch versus placebo patch and glucantime in the treatment of cutaneous leishmaniasis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138904091159N7
Enrollment
104
Registered
2013-09-02
Start date
2013-08-23
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 (any type)

Interventions

Intervention 1: Treatment of Nitroglycerin patch(the pharmacy of Nour and Ali Asghar hospital in Isfahan) 1 time every day covered nearly 2-3 inch of lesion + interlesional injection of placebo (injec
Treatment - Other
Treatment of Nitroglycerin patch(the pharmacy of Nour and Ali Asghar hospital in Isfahan) 1 time every day covered nearly 2-3 inch of lesion + interlesional injection of placebo (injection of distille
Interlesional injection of Glucantime(Meglusan) from Avenue de Scheut company in Belgica, 1 time every week, nearly 15-30 mg until whitening of base of the ulcer + treatment of placebo patch(the pharm

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1- Patients with a diagnosis of acute zoonotic cutaneous leishmaniasis has been proven parasitology by direct smear 2- Patients must be 18-50 age 3- Lesion diameter is not greater than 3 cm 4- The number of lesion is one 5- Lesions are not on the face near the eyes, joints, cartilage, on the nose and ears 6- Less than three months passed from diseases times. Exclusion Criteria: 1- The status of women in pregnancy and lactation 2- The risk of presence or incidence of sporotrichoid or Satellite lesions 3- Patients with a history of hepatitis, heart and kidney disorder 4- People who are taking immunosuppressive medications (over the last 6 months) 5- history of local or systemic treatment against leishmaniasis in the last 3 months 6- Patients with a history of heart attack or high blood pressure 7- Liver disease 8- Patients with anemia 9- Patients with a history of surgery for head and brain hemorrhage 10- Patients with blood pressure medications, antidepressants, or drugs used for angina.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Lesion area. Timepoint: 8, 12, 20 weeks after end of treatment. Method of measurement: Pictzar software.;Induration. Timepoint: 1, 2, 3, 4, 7, 8, 12, 16, 20 weeks after end of treatment. Method of measurement: Physical examination.;Improvement rate. Timepoint: 1, 2, 3, 4, 7, 8 weeks during treatment and 12, 16, 20 weeks after end of treatment. Method of measurement: Observation and examination.

Secondary

MeasureTime frame
Side effects. Timepoint: 3 months after treatment. Method of measurement: Observation and examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Shirani Bidabadi

Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ir

lshiranibidabadi@yahoo.com+98 31 1337 3736

Outcome results

None listed

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