Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT02535104
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
* Accept to follow study instructions / signature of IC
* Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.
Exclusion Criteria:
* Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
* Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
* Any of the following conditions:
* Known allergy to the study product
* Internal (rectal, urethral) warts that required or were undergoing treatment;
* A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation.
* Imiquimod 5% cream (Aldara®)
* Any marketed or investigational HPV vaccines
* Sinecatechins (Veregen)
* Interferon or interferon inducers
* Cytotoxic drugs
* Immunomodulators or immunosuppressives
* Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
* Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza)
* Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment
* Podophyllotoxin/Podofilox in the treatment areas
* Any topical prescription medications in the treatment areas
* Dermatologic procedures or surgery in the treatment areas
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02535104
Study Brief:
Protocol Section:
NCT02535104