Genital Warts
Conditions
Keywords
Photodynamic Therapy，PDT, Conventional, Painless, Genital Warts
Brief summary
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.
Interventions
Aminolevulinic acid photodynamic therapy
Sponsors
Shanghai Dermatology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluator assesses photographs without prior knowledge of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosed with Genital Warts; 2. Aged \> 18 years; 3. All patients are unfit and reluctant to undergo surgery for any reasons, and volunteered to participate in the study and ability to understand and the willingness to sign a written informed consent. Patents agreed to take a picture of the skin lesions. 4. The maximum diameter of a single carcass does not exceed 0.5cm; the skin lesions are at least 6 or more or substantially symmetric
Exclusion criteria
1. Those who did not complete the informed consent; 2. The lesions belongs to any of the following conditions: There is damage and inflammation, which may lead to the drug entering the open wound; the individual corpus callosum is more than 0.5cm in diameter; the corpus callosum is located in the vagina, the anal canal, the cervix; 3. Patients with skin photoallergic diseases, porphyria; 4. Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs; 5. Patients with other obvious diseases that may affect the evaluation of efficacy; (6)Scars or patients with a tendency to form scars; (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The clearance rate of Genital Warts | one week after the last treatment | The clearance rate of Genital Warts will be measured at one week after the last treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 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 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. |
| The recurrence rates after treatment | 3 months after the last treatment | The recurrence rates will be measured at 3 months after the last treatment. |
Countries
China
Contacts
Primary ContactHaiyan Zhang, MD
Backup ContactYunfeng Zhang, MD
Outcome results
None listed