Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00840359
First received: February 8, 2009
Last updated: August 15, 2011
Last verified: August 2011

February 8, 2009
August 15, 2011
September 2009
October 2012   (final data collection date for primary outcome measure)
Eradiation of amastigotes [ Time Frame: 3 months following last treatment session ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00840359 on ClinicalTrials.gov Archive Site
Clinical healing [ Time Frame: 3 months following last treatment session ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
Phase 2 Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis

The aim of the project is to determine whether daylight activated photodynamic therapy is effective in treating cutaneous leishmaniasis caused by L. major and L. tropical.

PDT is classically performed as a two-step procedure in which MAL application to the lesion constitutes the first step, and PpIX activation by light of appropriate wavelength from an artificial light source constitutes the second step. Based on the knowledge that red and blue light required to activate PpIX are part of the daylight spectrum, the investigators postulated that effective PpIX activation can be obtained by exposure of the MAL treated lesions to daylight thus substantially simplifying the PDT procedure by omitting the 3 hour incubation period and the subsequent exposure to artificial light. In accord, in a recent study the investigators showed that daylight-activated PDT (DA-PDT) was as effective as conventional MAL-PDT in treating precancerous actinic keratoses lesion. Furthermore the investigators found that DA-PDT is significantly less painful than conventional MAL-PDT.

The investigators now propose to study the efficacy of DA-PDT in the treatment of cutaneous leishmaniasis. DA-PDT has obvious advantages to conventional leishmania treatment forms:

As opposed to most of the available treatment options, DA-PDT is a self-administered procedure that does not require the assistance of medical personnel. Secondly, judged by our experience with MAL-PDT, only few treatment sessions are required for effective parasite killing as opposed to the prolonged procedures usually required for treatment of leishmaniasis. Third, PDT has the far the best safety profile of all available treatment options.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous Leishmaniasis
  • Procedure: Photodynamic therapy
    Application of Metvix 16% cream followed by exposure to daylight for 2.5 hours
  • Procedure: Cryotherapy
    Cryotherapy for 2 times 20 sec
  • Experimental: 1 PDT
    Leishmania lesion
    Intervention: Procedure: Photodynamic therapy
  • Active Comparator: Cryo
    Leishmania lesion
    Intervention: Procedure: Cryotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
44
December 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least 2 skin lesions with leishmania caused by L. major or L. tropica

Exclusion Criteria:

  • Pregnant or lactating women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00840359
LeishDAPDT-HMO-CTIL
No
Prof. Claes D. Enk, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Claes D Enk, MD, PhD Hadassah Medical Organization
Hadassah Medical Organization
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP