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CompletedNCT00947362rtt-ACLUpdated Aug 8, 2025

Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

A Phase 2/3 interventional study of Electro-thermo-coagulation and DAC N-055 in Wound Healing, sponsored by Waisenmedizin e. V. Promoting Access to Essential Medicine. Completed at 1 site in Afghanistan. Open to participants aged 5 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Waisenmedizin e. V. Promoting Access to Essential Medicine · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Aug 2004, registered Jul 2009).
Phase
Phase 2/3
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
5 Years to 99 Years
Sex
All
01

Study summary

The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is:

  • to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years;
  • to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.
02

Conditions studied

  • Wound Healing
03

In context

Lead sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at least one suspected lesion positive in Giemsa smear

Exclusion criteria

Exclusion Criteria:

  • patients previously treated for leishmania
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
134 participants (actual)

Study arms

  • Experimental
    ETC + DAC N-055

    Other: Electro-thermo-coagulation · Drug: DAC N-055

  • Active comparator
    ETC + physiological saline

    Other: Electro-thermo-coagulation · Drug: saline

Interventions

  • OtherElectro-thermo-coagulation
  • DrugDAC N-055

    moist wound treatment plus 0.05 % pharmaceutical chlorite

  • Drugsaline

    physiological saline

06

What researchers measure

Primary outcomes

  1. Days for wound closure

    Days for primary wound closure

    Time frame: From the day of treatment start to the day of "wound closure"

Secondary outcomes

  1. Leishmania parasites load per gram of tissue before and after treatment

    Parasite load per gram of tissue

    Time frame: Before treatment start and at day "wound closure"

07

Study locations

1 site
  • German Medical Service
    Kabul, Kabul, Afghanistan
08

References and documents

Publications

  • Jebran AF, Schleicher U, Steiner R, Wentker P, Mahfuz F, Stahl HC, Amin FM, Bogdan C, Stahl KW. Rapid healing of cutaneous leishmaniasis by high-frequency electrocauterization and hydrogel wound care with or without DAC N-055: a randomized controlled phase IIa trial in Kabul. PLoS Negl Trop Dis. 2014 Feb 13;8(2):e2694. doi: 10.1371/journal.pntd.0002694. eCollection 2014 Feb. PubMed 24551257 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00947362
Lead sponsor
Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborators
German Medical Service (GMS) in Kabul, University of Freiburg
Responsible party
Kurt-Wilhelm Stahl (Chairman, Waisenmedizin e. V. Promoting Access to Essential Medicine) — Principal investigator
First posted
Jul 28, 2009
Start date
Aug 1, 2004
Primary completion
Dec 15, 2007
Completion
Dec 15, 2007
Last update
Aug 8, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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