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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
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical healing [ Time Frame: 3 months following last treatment session ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840359

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

No publications provided

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

Keywords provided by Hadassah Medical Organization:
Cutaneous leishmaniasis
Photodynamic therapy

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Parasitic Diseases
Protozoan Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic

ClinicalTrials.gov processed this record on November 25, 2014