Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 1 PDT
Procedure: Photodynamic therapy
Application of Metvix 16% cream followed by exposure to daylight for 2.5 hours
Active Comparator: Cryo
Cryotherapy for 2 times 20 sec
- Eradiation of amastigotes [ Time Frame: 3 months following last treatment session ]
- Clinical healing [ Time Frame: 3 months following last treatment session ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840359
|Hadassah Medical Organization|
|Jerusalem, Israel, IL-91010|
|Principal Investigator:||Claes D Enk, MD, PhD||Hadassah Medical Organization|