Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)
- Signed consent form.
- Male or non-pregnant, non-lactating female, ≥ 18 years.
- Must have a previously untreated, histologically confirmed nBCC on head, neck, trunk
- 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
- 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
- Participation in another clinical trial within one month before start of the trial.