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

Genital Warts Clinical Trial

Official title:

Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts：a Randomized, Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948321
• Other study ID #: 2019-09
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2019
• Source: Shanghai Dermatology Hospital
• Contact: Haiyan Zhang, MD
• Phone: +86-18017336573
• Email: zhanghaiyan10842[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Condylomata Acuminata
• Genital Warts
• Warts

Intervention

Procedure:
• Aminolevulinic acid photodynamic therapy
Aminolevulinic acid photodynamic therapy

Locations

Country	Name	City	State
China	Shanghai Dermatology Hospital	Shanghai	Shanghai, Jingan, China

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Dermatology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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
Secondary	The recurrence rates after treatment	The recurrence rates will be measured at 3 months after the last treatment.	3 months after the last treatment