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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03948321
Other study ID # 2019-09
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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