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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 1994 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155584
First received: September 9, 2005
Last updated: NA
Last verified: December 1994
History: No changes posted
  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 3

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: Topical 5-Aminolevulinic Acid Photodynamic Therapy for the Treatment of Verruca Vulgaris: Comparison of Red and Green Light-Emitting Diode Array

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 80
Study Start Date: December 1994
Estimated Study Completion Date: December 1996
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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Warts -

Exclusion Criteria:

other skin lesions or combined with infection -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155584     History of Changes
Other Study ID Numbers: 28MD01
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on September 22, 2014