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This study is being done to compare a new, continuous illumination and short Incubation time regimen of aminolevulinic acid photodynamic therapy(ALA-PDT) to a conventional regimen for treatment of small genital warts. The hypothesis is that the continuous illumination approach will be less or even no painful, but equally efficacious, as the old regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Painless Photodynamic Therapy(P-PDT) | Experimental | The painless photodynamic therapy(P-PDT)group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 400 J/cm2) after applying 20% 5-aminolevulinic acid(ALA)cream for 30min. A repeat treatment was administered once weekly for a maximum of 3 weeks. |
|
| Conventional Photodynamic Therapy(C-PDT) | Active Comparator | The conventional photodynamic therapy(C-PDT) group underwent narrow-band light-emitting diode (LED) irradiation (630 nm; 100 J/cm2) after applying 20% 5-aminolevulinic acid cream for 3h.A repeat treatment was administered once weekly for a maximum of 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic acid photodynamic therapy | Procedure | Aminolevulinic acid photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The clearance rate of Genital Warts | The clearance rate of Genital Warts will be measured at one week after the last treatment. | one week after the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | The pain will be assessed using Visual Analogue Scale(VAS) with a score range of 0-10. The higher the score, the greater the pain, with 0 being no pain and 10 being the most unbearable pain. Pain will be measured at different time points during and after every treatment ,including immediately, 1st min, 3rd min, 5th min, 7th min, 10th min , and every 10 min to the end of treatment and 2nd h, 12th h, 24th h and 48th h after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
(7)Known to have severe immune dysfunction, or long-term use of glucocorticoids and immunosuppressants; (8)Severe heart, liver, kidney disease; with hereditary or acquired People with sexual coagulopathy; (9)Those with severe neurological, psychiatric or endocrine diseases; (10)Women who are pregnant, breast-feeding or using inappropriate contraceptives; those with a history of drug abuse; those who have participated in other drug clinical trials within 4 weeks before treatment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Zhang, MD | Contact | +86-18017336573 | zhanghaiyan10842@163.com | |
| Yunfeng Zhang, MD | Contact | 86-18017336550 | yunfeng0519116@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiuli Wang, PhD, MD | Shanghai Skin Disease Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dermatology Hospital | Recruiting | Shanghai | Shanghai, Jingan, China | 200443 | China |
underlie results
One year after finishing this study and for permanency
anyone who search pubmed
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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Evaluator assesses photographs without prior knowledge of intervention
| Immediately, 1st minute, 3rd minute, 5th minute, 7th minute, 10th minute , and every 10 minute to the end of treatment and 2 hours, 12 hours, 24hours and 48 hours after treatment |
| The recurrence rates after treatment | The recurrence rates will be measured at 3 months after the last treatment. | 3 months after the last treatment |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |