NCT00996463

Brief Summary

The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:

  1. 1.The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
  2. 2.The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 28, 2011

Status Verified

October 1, 2009

Enrollment Period

8 months

First QC Date

October 15, 2009

Last Update Submit

March 25, 2011

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

  • Wound closure time

    75 days

Secondary Outcomes (2)

  • Leishmania load parasites per gram of tissue before and after treatment

    75 days

  • Cost-effectiveness & -utility

    75 days

Study Arms (3)

IL SSG

ACTIVE COMPARATOR

Intralesional sodium stibogluconate

Drug: Sodium Stibogluconate

ETC+MWT

EXPERIMENTAL

Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Procedure: Electro-thermo-coagulationDrug: DAC N-055

MWT

EXPERIMENTAL

Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Drug: DAC N-055

Interventions

Electro-thermo-coagulationPROCEDURE

Electro-thermo-coagulation

ETC+MWT
Sodium StibogluconateDRUG

Intralesional injection of sodium stibogluconate

IL SSG
DAC N-055DRUG

Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

ETC+MWTMWT

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who
  • Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.

You may not qualify if:

  • Patients with more than one lesion are excluded.
  • Patients with a lesion age of \> 3 months are also excluded. The experience of the Kabul trial shows that patients presenting themselves for the first time with a lesion, which is older than three months, have either been pre-treated somewhere else and/or show a poor compliance during the trial.
  • Patients below 12 years of age have to be excluded from the trial, because they cannot fill in the EQ-5D and Skindex questionnaire part of the health economic evaluation.
  • Intralesional antimony injections are too painful for lesions located on the nose, lips or eyes. Therefore, patients presenting these lesions are excluded from the trial.
  • For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial.
  • Patients with major uncontrolled diseases as tuberculosis, diabetes or HIV are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leishmaniasis and Malaria Center

Mazari Sharif, Balkh, Afghanistan

Location

Related Publications (1)

  • Stahl HC, Ahmadi F, Schleicher U, Sauerborn R, Bermejo JL, Amirih ML, Sakhayee I, Bogdan C, Stahl KW. A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan. BMC Infect Dis. 2014 Nov 25;14:619. doi: 10.1186/s12879-014-0619-8.

    PMID: 25420793DERIVED

MeSH Terms

Interventions

Antimony Sodium Gluconate

Intervention Hierarchy (Ancestors)

Organic ChemicalsGluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

March 28, 2011

Record last verified: 2009-10

Locations

AF(1)