Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2019
CompletedStudy Start
First participant enrolled
May 10, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedMay 29, 2019
May 1, 2019
8 months
May 9, 2019
May 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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 recurrence rates after treatment
3 months after the last treatment
Study Arms (2)
Painless Photodynamic Therapy（P-PDT）
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
Aminolevulinic acid photodynamic therapy
Eligibility Criteria
You may qualify if:
- Clinical diagnosed with Genital Warts;
- Aged \> 18 years;
- 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.
- The maximum diameter of a single carcass does not exceed 0.5cm; the skin lesions are at least 6 or more or substantially symmetric
You may not qualify if:
- Those who did not complete the informed consent;
- 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;
- Patients with skin photoallergic diseases, porphyria;
- Known to have a history of allergies to test drugs (porphyrins) and their chemically similar drugs;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Dermatology Hospital
Shanghai, Shanghai, Jingan, China, 200443, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiuli Wang, PhD, MD
Shanghai Skin Disease Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Evaluator assesses photographs without prior knowledge of intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Professor
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
May 10, 2019
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
May 29, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- One year after finishing this study and for permanency
- Access Criteria
- anyone who search pubmed
underlie results