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

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

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.

Study Overview

• Status: Unknown
• Conditions: Warts

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
• Enrollment: 80

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Warts -

Exclusion Criteria:

other skin lesions or combined with infection -

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Pan-Chyr Yang, Ph.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 1994
• Study Completion: December 1, 1996

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (ESTIMATE): September 12, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): September 12, 2005
• Last Update Submitted That Met QC Criteria: September 9, 2005
• Last Verified: December 1, 1994

More Information

Terms related to this study

• Keywords: 5-ALA; photodynamic therapy; warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: 28MD01