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

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ClinicalTrials.gov Identifier: NCT00155584
Recruitment Status : Unknown
Verified December 1994 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:

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 or disease Phase
Warts Phase 3

Detailed Description:

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.


Study Type : Observational
Estimated Enrollment : 80 participants
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Topical 5-Aminolevulinic Acid Photodynamic Therapy for the Treatment of Verruca Vulgaris: Comparison of Red and Green Light-Emitting Diode Array
Study Start Date : December 1994
Estimated Study Completion Date : December 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Warts -

Exclusion Criteria:

other skin lesions or combined with infection -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155584


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

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Hsiung-Fei Chien, MD, Ph.D.    886223123456 ext 5594    hfchien@ha.mc.ntu.edu.tw   
Sub-Investigator: Chin-Tin Chen, Ph.D.         
Principal Investigator: Hisung-Fei Chien, MD. Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Pan-Chyr Yang, Ph.D. National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT00155584     History of Changes
Other Study ID Numbers: 28MD01
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: December 1994

Keywords provided by National Taiwan University Hospital:
warts
photodynamic therapy
5-ALA

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases