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

NCT00840359 | Unknown Phase 2

• 1 other identifier: LeishDAPDT-HMO-CTIL
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous leishmaniasis; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Eradiation of amastigotes

  3 months following last treatment session

Secondary Outcomes (1)

• Clinical healing

  3 months following last treatment session

Study Arms (2)

1 PDT

EXPERIMENTAL

Leishmania lesion

Procedure: Photodynamic therapy

Cryo

ACTIVE COMPARATOR

Leishmania lesion

Procedure: Cryotherapy

Interventions

Photodynamic therapy PROCEDURE

Application of Metvix 16% cream followed by exposure to daylight for 2.5 hours

1 PDT

Cryotherapy PROCEDURE

Cryotherapy for 2 times 20 sec

Cryo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or lactating women

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, IL-91010, Israel

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Photochemotherapy; Cryotherapy

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Claes D Enk, MD, PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2009
• First Posted: February 10, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

IL (1)