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

Primary Purpose

Genital Warts

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Aminolevulinic acid photodynamic therapy

About this trial

This is an interventional treatment trial for Genital Warts focused on measuring Photodynamic Therapy，PDT, Conventional, Painless, Genital Warts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Shanghai Dermatology HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Painless Photodynamic Therapy（P-PDT）

Conventional Photodynamic Therapy（C-PDT）

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The clearance rate of Genital Warts

The clearance rate of Genital Warts will be measured at one week after the last treatment.

Secondary Outcome Measures

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.

The recurrence rates after treatment

The recurrence rates will be measured at 3 months after the last treatment.

Full Information

NCT ID

NCT03948321

First Posted

May 9, 2019

Last Updated

May 27, 2019

Sponsor

Shanghai Dermatology Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03948321

Brief Title

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

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Dermatology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genital Warts

Keywords

Photodynamic Therapy，PDT, Conventional, Painless, Genital Warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Evaluator assesses photographs without prior knowledge of intervention

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Painless Photodynamic Therapy（P-PDT）

Arm Type

Experimental

Arm Description

Arm Title

Conventional Photodynamic Therapy（C-PDT）

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Aminolevulinic acid photodynamic therapy

Intervention Description

Aminolevulinic acid photodynamic therapy

Primary Outcome Measure Information:

Title

The clearance rate of Genital Warts

Description

The clearance rate of Genital Warts will be measured at one week after the last treatment.

Time Frame

one week after the last treatment

Secondary Outcome Measure Information:

Title

Pain assessment

Description

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

Title

The recurrence rates after treatment

Description

The recurrence rates will be measured at 3 months after the last treatment.

Time Frame

3 months after the last treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Haiyan Zhang, MD

Phone

+86-18017336573

zhanghaiyan10842@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yunfeng Zhang, MD

Phone

86-18017336550

yunfeng0519116@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PhD, MD

Organizational Affiliation

Shanghai Skin Disease Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Dermatology Hospital

City

Shanghai

State/Province

Shanghai, Jingan, China

ZIP/Postal Code

200443

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haiyan Zhang, MD

Phone

+86-18017336573

zhanghaiyan10842@163.com

First Name & Middle Initial & Last Name & Degree

Yunfeng Zhang, MD

Phone

+86-18017336550

yunfeng0519116@aliyun.com

First Name & Middle Initial & Last Name & Degree

Xiuli Wang, PhD,MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

underlie results

IPD Sharing Time Frame

One year after finishing this study and for permanency

IPD Sharing Access Criteria

anyone who search pubmed

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

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