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

Efficacy of sinecatechins 10% as proactive sequential therapy of external and perianal genital warts after ablative therapy: A prospective randomized multicenter study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44037479
Enrollment
80
Registered
2018-03-22
Start date
2017-08-01
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External genital warts Infections and Infestations Anogenital warts

Interventions

Veregen (ointment formulation of 10% sinecatechins derived from green tea extract) was applied in the area of condyloma previously treated with laser or cryotherapy. Patients were instructed to apply

Sponsors

Cantabria Labs Difa Cooper
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Presence of multiple external genital warts eligible for ablative treatments

Exclusion criteria

Exclusion criteria: 1. HIV-positive subjects 2. Acute inflammatory skin disease

Design outcomes

Primary

MeasureTime frame
Recurrence of new external genital warts at 3 months after the last ablative treatment session

Secondary

MeasureTime frame
1. Tolerability 2. Safety profile 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).

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026