Clinical Trial: Topical 5-ALA Photodynamic Therapy for the Treatment of Verruca Vulgaris

This study is currently recruiting patients.
Verified by National Taiwan University Hospital December 1994

Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155584

Purpose

Photodynamic therapy (PDT) has been developed as a promising new cancer treatment modality, which involves the uptakes of a photosensitizer by tumor cells, followed by the activation of photosensitizer with approximate wavelength of light. The mechanisms of the PDT-induced cytotoxic effect relate to singlet oxygen and other reactive oxygen intermediates generated by PDT, which give rise to cellular stress and cause cell death. Previously, using the homemade LED light source, we have shown that ALA-PDT is effective for the treatment of premalignant lesions such as mucosal dysplasia and carcinoma in situ of oral cavity. Due to the advantages of low cost, high reliability, and portability, LED light source provides an alternative approach for the light irradiation of PDT.

Verruca vulgaris are benign skin papillomas caused by the human papilloma virus (HPV). They are very common and can affect many different sites including the face, hands, feet and genitalia. Although the present therapeutic approaches are more or less effective in eradicating the lesions, relapses are very common. Furthermore, at times the anatomical location and depth of lesions often make the treatment difficult, time-consuming and painful. Therefore, it is necessary to develop new modalities for wart treatment.

The purpose of this clinical trial is to develop topical ALA-PDT as an alternative treatment of wart but without the unwanted side effects of pain and burning. To fulfill this goal, the following works will be performed. First, topical ALA formulation and LED array will be specifically designed and developed for the skin lesions. Second, the efficacy of the ALA formulation designed for wart treatment will be evaluated with in vivo fluorescence imaging system. Third, the therapeutic efficacy of ALA-PDT will be evaluated by using a LED array designed for skin irradiation. Forth, the unwanted side effects of pain and burning will be further compared between red and green LED array.

Condition Phase
Warts
Phase III

MedlinePlus related topics:  Warts

Study Type: Observational
Study Design: Natural History, Longitudinal, Random Sample, Prospective Study

Official Title: Topical 5-Aminolevulinic Acid Photodynamic Therapy for the Treatment of Verruca Vulgaris: Comparison of Red and Green Light-Emitting Diode Array

Further Study Details: 

Expected Total Enrollment:  80

Study start: December 1994;  Expected completion: December 1996
Last follow-up: December 1996;  Data entry closure: December 1996

Verruca vulgaris or warts are benign skin papillomas caused by the human papilloma virus (HPV). They are very common and can affect many different sites including the face, hands, feet and genitalia. Although the present therapeutic approaches are more or less effective in eradicating the lesions, scars and relapses are very common. Furthermore, at times the anatomical location and depth of lesions often make the treatment difficult, time-consuming and painful. Therefore, it is necessary to develop new modalities for wart treatment.

Photodynamic therapy (PDT) has been developed as a promising new cancer treatment modality, which involves the uptakes of a photosensitizer by tumor cells, followed by the activation of photosensitizer with approximate wavelength of light. The endogenous conversion of 5-aminolevulinic acid (ALA) to protoporphyrin IX (PpIX) has broadened the use of PDT. The mechanisms of the PDT-induced cytotoxic effect relate to singlet oxygen and other reactive oxygen intermediates generated by PDT, which give rise to cellular stress and cause cell death. Previously, using the homemade LED light source, we have shown that topical ALA-PDT is effective for the treatment of warts. However, the excruciating pain induced by ALA and red LED could be due to deeper penetration of the ALA formulation or the deeper penetration of red light. Thus the pain might be related to the injured nerve fibers underlying the skin. This study is to provide evidence of these two green or red LED efficacy in removing the warts and also their side-effect of pain.

Eligibility

Ages Eligible for Study:  10 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Warts -

Exclusion Criteria:

other skin lesions or combined with infection -

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00155584

Hsiung-Fei Chien, MD, Ph.D.      886223916762    hfchien@ha.mc.ntu.edu.tw

Taiwan
      National Taiwan University Hospital, Taipei,  Taiwan; Recruiting
Hsiung-Fei Chien, MD, Ph.D.  886223123456  Ext. 5594    hfchien@ha.mc.ntu.edu.tw 
Chin-Tin Chen, Ph.D.,  Sub-Investigator
Hisung-Fei Chien, MD. Ph.D.,  Principal Investigator

Study chairs or principal investigators

Pan-Chyr Yang, Ph.D.,  Study Director,  National Taiwan University Hospital   

More Information

Study ID Numbers:  28MD01
Last Updated:  September 9, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00155584
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13

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