ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000115235

Ethics application status

Approved

Date submitted

30/12/2008

Date registered

18/02/2009

Date last updated

5/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

comparison between Intralesional injection of 2% zinc sulfate and intralesional glucantime in treatment of cutaneous leishmaniasis.

Scientific title

comparison between Intralesional injection of 2% zinc sulfate and intralesional glucantime in treatment of cutaneous leishmaniasis.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

leishmaniasis

Condition category

Condition code

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

intraleisional injection of zinc sulfate 2% vial once every week until 10 weeks or until complete healing if happened earliear plus crotherapy at -196 degree celsius (liqiud nitrogen) once every other week until 10 weeks or until complete healing if happened earliear; it is performed as contact cryotherapy for 5-10 sec to the infected site

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

intralesional glucantime (435 mg of sb5+, active antimony) 15 mg/kg of active ingredient (antimony) once every week until 10 weeks or until complete healing if happened earliear plus crotherapy at -196 degree celsius (liqiud nitrogen) once every other week until 10 weeks or until complete healing if happened earliear ; it is performed as contact cryotherapy for 5-10 sec to the infected site

Control group

Active

Outcomes

Primary outcome [1]

size of induration is measured with a transparent paper by an independed observer who was blind to the treat options

Timepoint [1]

'size of induration' is measured 'every 2 weeks until 10 weeks ( end of treatment); 2weeks after end of treatment and 3 months after end of treatment

Secondary outcome [1]

smear for leishmaniasis

Timepoint [1]

smear is taken at the end of treatment; 2weeks and 3 months after the end of treatment

Eligibility

Key inclusion criteria

the patients with urban cutaneous leishmaniasis with the onset of lower than 3 months

Minimum age

5 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

taking any treatment of leishmaniasis within last month

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

block randomisation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Iran, Islamic Republic Of

State/province [1]

Kerman

Funding & Sponsors

Funding source category [1]

University

Name [1]

Kerman medical university

Address [1]

Kerman medical university,Kerman,Iran

Country [1]

Iran, Islamic Republic Of

Primary sponsor type

University

Name

Kerman medical university

Address

Kerman medical university,Kerman,Iran

Country

Iran, Islamic Republic Of

Secondary sponsor category [1]

Hospital

Name [1]

Afzalipour hospital

Address [1]

Afzalipour hospital,Kerman,Iran

Country [1]

Iran, Islamic Republic Of

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ethical committe of Kerman medical University

Ethics committee address [1]

Ethics committee country [1]

Iran, Islamic Republic Of

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

k-25/35

Summary

Brief summary

Leishmaniasis is a parasitic disease  that is endemic in developing countries such as our country. The incidence of leishmaniasis is more than 400,000 cases  annually and the prevalence of all form of leishmaniasis is more than twelve millions.
Although cutaneous leishmaniasis (CL) is a self- healing disease , the duration of the disease is long and requeries several months and somtimes years before complete recovery , depending on the species of the infecting parasite . After recovery, a disfiguring scar can be left , which may destroy underlying structures like the nose or ear or cause psychological suffering of patients.
The first line drug for treatment of CL., according to WHO recommendation , is the pentavalent comounds such as meglomine antimoniate (Glucantime )
Other treatment for cutaneous leishmaniasis are intralesinal injection of meglomine antimonate, terbinafine , paramonycin ointment ,   and physical treatment including cryotherapy (cryosurgery) .In recent researches,zinc  sulfate was studied in the treatment of this disease.But there are some contravesies.The aim of this study is the comparision of intralesional injection of zinc sulfate with intralesional glucantim in the treatment of cutaneou leishmaniasis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Armita Shahesmaeili

Address

Clinical research department, Afzalipour hospital,Kerman,Iran

Country

Iran, Islamic Republic Of

Phone

09133406291

Fax

0098-0341-322-2270

[email protected]

Contact person for scientific queries

Name

Saeedeh Farajzadeh

Address

dermatilogy ward,Afzalipour hospital,Kerman,Iran

Country

Iran, Islamic Republic Of

Phone

09133414259

Fax

0098-0341-322-2270

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Comparison between intralesional injection of zinc sulfate 2 % solution and intralesional meglumine antimoniate in the treatment of acute old world dry type cutaneous leishmaniasis: a randomized double-blind clinical trial.	2016	https://dx.doi.org/10.1007/s12639-014-0609-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically