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
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30236042