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Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts

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ClinicalTrials.gov Identifier: NCT03948321
Recruitment Status : Unknown
Verified May 2019 by Xiuli Wang, Shanghai Dermatology Hospital.
Recruitment status was:  Recruiting
First Posted : May 13, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Xiuli Wang, Shanghai Dermatology Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Genital Warts Procedure: Aminolevulinic acid photodynamic therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Evaluator assesses photographs without prior knowledge of intervention
Primary Purpose: Treatment
Official Title: Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts：a Randomized, Open-label Trial
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arms and Interventions
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Arm Intervention/treatment
Experimental: Painless Photodynamic Therapy（P-PDT）
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.
 Procedure: Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy
Active Comparator: Conventional Photodynamic Therapy（C-PDT）
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.
 Procedure: Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy


Outcome Measures
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Primary Outcome Measures :
  1. The clearance rate of Genital Warts [ Time Frame: one week after the last treatment ]
    The clearance rate of Genital Warts will be measured at one week after the last treatment.


Secondary Outcome Measures :
  1. Pain assessment [ Time Frame: 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.

  2. The recurrence rates after treatment [ Time Frame: 3 months after the last treatment ]
    The recurrence rates will be measured at 3 months after the last treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948321


Contacts
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Contact: Haiyan Zhang, MD +86-18017336573 zhanghaiyan10842@163.com
Contact: Yunfeng Zhang, MD 86-18017336550 yunfeng0519116@aliyun.com

Locations
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China, Shanghai, Jingan, China
Shanghai Dermatology Hospital Recruiting
Shanghai, Shanghai, Jingan, China, China, 200443
Contact: Haiyan Zhang, MD    +86-18017336573    zhanghaiyan10842@163.com   
Contact: Yunfeng Zhang, MD    +86-18017336550    yunfeng0519116@aliyun.com   
Principal Investigator: Xiuli Wang, PhD,MD         
Sponsors and Collaborators
Shanghai Dermatology Hospital
Investigators
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Study Chair: Xiuli Wang, PhD, MD Shanghai Skin Disease Hospital
More Information
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Responsible Party: Xiuli Wang, Director, Clinical Professor, Shanghai Dermatology Hospital
ClinicalTrials.gov Identifier: NCT03948321    
Other Study ID Numbers: 2019-09
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: underlie results
Supporting Materials: Clinical Study Report (CSR)
Time Frame: One year after finishing this study and for permanency
Access Criteria: anyone who search pubmed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Wang, Shanghai Dermatology Hospital:
Photodynamic Therapy，PDT
Conventional
Painless
Genital Warts
Additional relevant MeSH terms:
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Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Skin Diseases, Viral
Tumor Virus Infections
 Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Communicable Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents