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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Hadassah Medical Organization.
Recruitment status was:  Enrolling by invitation
Information provided by:
Hadassah Medical Organization Identifier:
First received: February 8, 2009
Last updated: August 15, 2011
Last verified: August 2011

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 Intervention Phase
Cutaneous Leishmaniasis
Procedure: Photodynamic therapy
Procedure: Cryotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

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

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

Estimated Enrollment: 44
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00840359

Hadassah Medical Organization
Jerusalem, Israel, IL-91010
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Claes D Enk, MD, PhD Hadassah Medical Organization
  More Information

Responsible Party: Prof. Claes D. Enk, Hadassah Medical Organization Identifier: NCT00840359     History of Changes
Other Study ID Numbers: LeishDAPDT-HMO-CTIL
Study First Received: February 8, 2009
Last Updated: August 15, 2011

Keywords provided by Hadassah Medical Organization:
Cutaneous leishmaniasis
Photodynamic therapy

Additional relevant MeSH terms:
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases processed this record on April 25, 2017