Prevention of recurrence of genital wart lesions after laser and cryotherapy using green tea extract
| ISRCTN | ISRCTN44037479 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44037479 |
| Secondary identifying numbers | VEREGEN1/17 |
- Submission date
- 12/03/2018
- Registration date
- 22/03/2018
- Last edited
- 19/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39029659031 |
|---|---|
| massimo.milani@difacooper.com |
Study information
| Study design | Prospective controlled randomized parallel group (3:1) masked-outcome assessment multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy of sinecatechins 10% as proactive sequential therapy of external and perianal genital warts after ablative therapy: A prospective randomized multicenter study |
| Study objectives | 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(s) | IRB of Tor Vergata University, 12/07/2017, RS 116/17 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2017 |
| Completion date | 28/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 (with a 3:1 balanced design) |
| Key inclusion criteria | Presence of multiple external genital warts eligible for ablative treatments |
| Key exclusion criteria | 1. HIV-positive subjects 2. Acute inflammatory skin disease |
| Date of first enrolment | 01/08/2017 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- Italy
Study participating centres
Rome
00133
Italy
100200
Italy
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | 0039029659031 |
|---|---|
| massimo.milani@difacooper.com | |
"ROR" |
https://ror.org/044sr7e96 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The plan is to submit the manuscript to an international peer-review journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2019 | Yes | No | |
| Results article | Follow up | 01/02/2022 | 19/05/2023 | Yes | No |
Editorial Notes
19/05/2023: Publication reference added.
11/12/2018: Publication reference added.
