Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00840359
Recruitment Status : Unknown
Verified August 2011 by Hadassah Medical Organization.
Recruitment status was:  Enrolling by invitation
First Posted : February 10, 2009
Last Update Posted : August 16, 2011
Information provided by:
Hadassah Medical Organization

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Procedure: Photodynamic therapy Procedure: Cryotherapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
Study Start Date : September 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
Experimental: 1 PDT
Leishmania lesion
Procedure: Photodynamic therapy
Application of Metvix 16% cream followed by exposure to daylight for 2.5 hours

Active Comparator: Cryo
Leishmania lesion
Procedure: Cryotherapy
Cryotherapy for 2 times 20 sec

Primary Outcome Measures :
  1. Eradiation of amastigotes [ Time Frame: 3 months following last treatment session ]

Secondary Outcome Measures :
  1. Clinical healing [ Time Frame: 3 months following last treatment session ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00840359

Layout table for location information
Hadassah Medical Organization
Jerusalem, Israel, IL-91010
Sponsors and Collaborators
Hadassah Medical Organization
Layout table for investigator information
Principal Investigator: Claes D Enk, MD, PhD Hadassah Medical Organization
Layout table for additonal information
Responsible Party: Prof. Claes D. Enk, Hadassah Medical Organization Identifier: NCT00840359    
Other Study ID Numbers: LeishDAPDT-HMO-CTIL
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011
Keywords provided by Hadassah Medical Organization:
Cutaneous leishmaniasis
Photodynamic therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases