Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155584
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-09
Brief Title:
Topical 5-ALA Photodynamic Therapy for the Treatment of Verruca Vulgaris
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Topical 5-Aminolevulinic Acid Photodynamic Therapy for the Treatment of Verruca Vulgaris Comparison of Red and Green Light-Emitting Diode Array
Status:
UNKNOWN
Status Verified Date:
1994-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None