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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00314756
Eligibility Criteria:
Inclusion Criteria:
1. Are willing and able to give informed consent;
2. Are at least 18 years of age;
3. Are willing to comply with all study requirements, evaluations, and procedures
4. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
* a primary lesion (not recurrent, not previously treated or biopsied)
* non-infected
* size between 0.25 and 1.5 cm2
* located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
* clinically consistent with nodular BCC
* histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
* suitable for treatment with surgical excision
* easily identifiable and treatable by subject or reliable subject representative
5. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
6. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.
Exclusion Criteria:
1. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
2. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
3. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
4. Are pregnant at the screening or treatment initiation visit.
5. Have known allergies to any excipient in the study cream
6. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00314756
Study Brief:
Protocol Section:
NCT00314756