Prevention of recurrence of genital wart lesions after laser and cryotherapy using green tea extract

Phase 4

Completed

• Conditions: External genital warts; Infections and Infestations; Anogenital warts

• Registration Number: ISRCTN44037479
• Lead Sponsor: Cantabria Labs Difa Cooper

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30236042 results 2022 Results article in https://doi.org/10.23736/S2784-8671.21.06894-2 Follow up (added 19/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-28
• Study Start: 2018-03-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Presence of multiple external genital warts eligible for ablative treatments

Exclusion Criteria

1. HIV-positive subjects
2. Acute inflammatory skin disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of new external genital warts at 3 months after the last ablative treatment session

Secondary Outcome Measures

Name	Time	Method
1. Tolerability<br>2. Safety profile <br>At each study visit at months 1, 2 and 3, the investigator assessed local skin signs, including erythema, oedema, induration, vesicles, erosion /ulceration, other skin signs and overall skin signs, and the patient was questioned about local skin symptoms, including burning, itching, pain, other skin symptoms and overall skin symptoms. Intensity of all skin reactions at the site of application was graded as: none, mild (local skin reaction which can be easily tolerated), moderate (local skin reaction which is associated with considerable discomfort, but does not prevent usual activity), or severe (local skin reaction which substantially interferes with the patient’s usual activity).