Clinical trial NCT03948321: Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts
Official title: Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts：a Randomized, Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genital Warts
Keywords: Photodynamic Therapy，PDT
Conventional
Painless
Genital Warts
Lead sponsor: Shanghai Dermatology Hospital
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The clearance rate of Genital Warts
timeFrame: one week after the last treatment
Secondary outcomes:
measure: Pain assessment
timeFrame: 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
measure: The recurrence rates after treatment
timeFrame: 3 months after the last treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai, Jingan, China
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Xiuli Wang, PhD, MD
role: STUDY_CHAIR
References: