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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT01808950
Eligibility Criteria:
Inclusion Criteria:
* Signed consent form.
* Male or non-pregnant, non-lactating female, ≥ 18 years.
* Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk or arms.
* nBCC must not be larger than 20 mm in diameter and must be less than 5 mm in depth.
* Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
Exclusion Criteria:
* nBCC located close to or at mouth or eyes.
* Patients who have had an organ transplant.
* Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression.
* An open wound or an infection in treatment area.
* Dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments.
* Evidence of an active infection or systemic cancer.
* Flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial.
* Known allergy or hypersensitivity to any of the trial gel ingredients.
* Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease).
* Current alcohol abuse or chemical dependency as assessed by the investigator.
* Patient who is detained or committed to an institution by a law court or by legal authorities.
* Participation in another clinical trial within one month before start of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01808950
Study Brief:
Protocol Section:
NCT01808950