Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is the observation and description of the preliminary efficacy of resiquimod gel 0.06% on a single nodular basal cell carcinoma (nBCC) in a small group of patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spirig Pharma Ltd.

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.