Condition category
Infections and Infestations
Date applied
12/03/2018
Date assigned
22/03/2018
Last edited
22/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
External genital warts (EGW) are the most common viral sexually transmitted infection. Ablative treatments like cryotherapy, curettage and CO2 laser therapy offer rapid onset of effect, fast clearance, and reduction of viral load. However, these procedures are associated with high recurrence rates (RR) of 20–77% in the short and medium term and do not provide sustained clearance. After laser therapy removal of EGW, a RR up to 60% has been reported. Topical sinecatechins 10% is a patient-applied regimen for the treatment of EGW with a low RR (6.5%) at 3 months after completion of the therapy in the pivotal trials conducted so far. Sinecatechins can be considered a suitable proactive sequential therapy (PST) after ablative strategies to obtain a low RR. No prospective data are available so far regarding the efficacy of sinecatechins 10% as PST. We evaluated, the efficacy and tolerability of topical sinecatechins 10% applied twice daily in subjects with recurrent EGW after ablative therapies with CO2 laser or cryotherapy in a multicenter randomised masked outcome trial trial.

Who can participate?
Adults with multiple external genital warts.

What does the study involve?
The treatment is an ointment containing sinecatechins extracted from green tea. The ointment is applied twice a day to areas where genital warts have been removed using laser or cryotherapy.

What are the possible benefits and risks of participating?
The ointment of green tea extract evaluated in this trial can be considered safe because no systemic side effects have been recorded in clinical trials performed in more than 1500 subjects so far. Self-limited, (in general mild or moderate), local reactions like burning and itching sensations might be observed in up to 60% of the subjects but these side effects disappear in few days. The potential benefit is the preventive effect in lowering recurrence percentage of new genital warts lesions, therefore reducing the need for, and associated risk, time loss and cost of, additional ablative procedures (laser, cryotherapy etc).

Where is the study run from?
The study is run from the Dermatology Clinic, University Tor Vergata Rome. There are four centres in total.

When is the study starting and how long is it expected to run for?
The study started in June 2017 and finished in February 2018.

How long will the trial be recruiting participants for?
The trial recruited between August and October 2017.

Who is the main contact?
Dr Massimo Milani (massimo.milani@difacooper.com)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Massimo Milani

ORCID ID

Contact details

Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

VEREGEN1/17

Study information

Scientific title

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

Acronym

Study hypothesis

To assess if the use of topical sinecatechins 10% (green tea extract) as sequential proactive treatment after ablative therapies (laser cryotherapy) could reduce the risk of recurrence of new genital wart lesions

Ethics approval

IRB of Tor Vergata University, 12/07/2017, RS 116/17

Study design

Prospective controlled randomized parallel group (3:1) masked-outcome assessment multicenter trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

External genital warts

Intervention

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 the ointment twice daily, at 12-h intervals, for 3 months. Control group patients received no treatment after ablation.

Intervention type

Drug

Phase

Phase IV

Drug names

Veregen (topical 10% sinecatechins: green tea extract)

Primary outcome measure

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

Secondary outcome measures

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).

Overall trial start date

01/06/2017

Overall trial end date

28/02/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Presence of multiple external genital warts eligible for ablative treatments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 (with a 3:1 balanced design)

Participant exclusion criteria

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

Recruitment start date

01/08/2017

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Italy

Trial participating centre

Dermatology Clinic University Tor Vergata Rome
Viale Oxford, 81 - 00133 Roma
Rome
00133
Italy

Trial participating centre

Dermatology Clinic University of Catania
Catania
100200
Italy

Sponsor information

Organisation

Cantabria Labs Difa Cooper

Sponsor details

Via Milano 160
Caronno Pertusella
21042
Italy
0039029659031
massimo.milani@difacooper.com

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Difa Cooper

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan is to submit the manuscript to an international peer-review journal

Intention to publish date

01/06/2018

Participant level data

Stored in repository

Basic results (scientific)

A total of 87 subjects were enrolled. 60 treated with topical sinecatechins (TS) 10% for 3 months after a successful CO2 laser or cryotherapy sessions and 27 subjects as control (CTR; no sequential therapy) (6:1). All patients had an history of an average of 4.5 previous ablative treatments in the last 12 months due to recurrent EGW.

Publication list

Publication citations

Additional files

Editorial Notes