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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02015260
Eligibility Criteria:
Inclusion Criteria:
* Males and females over 18 years of age
* 2-50 warts in the anogenital region.
* Female patients of child-bearing potential had to be willing to use a non-barrier method of contraception at entry and for the duration of the study.
* all patients had to be willing to use barrier protection for the duration of the study.
* All patients had to be able to comply with the requirements of the protocol and be likely to return for follow-up visits and had to be contactable for the duration of the study.
Exclusion Criteria:
* Patients with clinically relevant abnormal haematology or biochemistry results (determined from the sample taken at Visit 1).
* Patients who had used an active therapy for anogenital warts within 2 weeks of randomisation to study drug, i.e. Visit 2.
* Patients who had used any local supportive medication, including topical corticosteroids or beta-interferon, within 2 weeks of study entry.
* Patients who had used medication known to adversely affect their haematology profile, including local anaesthetics (benzocaine, lidocaine, etc), nitrofurantoin, sulphonylureas and sulphonamides within 2 weeks of study entry. \[Word 'adversely' added by Protocol Amendment 2, 7 May 2002.\]
* Patients with abnormal anogenital skin, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
* Patients who were known to have a concomitant sexually transmitted disease that inhibited accurate assessment of their warts.
* Patients who required treatment other than surgery or laser for internal warts.
* Male patients with intra-urethral warts \[deleted by Protocol Amendment 2, 7 May 2002\].
* Patients with diabetes (Type I or Type II diabetes).
* Patients who were known to be HIV-positive.
* Patients who were known to be immunosuppressed and/or using immunosuppressive therapies.
* Patients known to abuse alcohol and/or drugs or with a history of chronic alcohol or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02015260
Study Brief:
Protocol Section:
NCT02015260