Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis
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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 |
- Eradiation of amastigotes [ Time Frame: 3 months following last treatment session ] [ Designated as safety issue: No ]
- 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 |
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
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 Protozoan Infections |
Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013