Status:
TERMINATED
Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
Lead Sponsor:
Spirig Pharma Ltd.
Conditions:
Nodular Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
efficacy assessments: * Histopathological findings based on the biopsies of the primary tumor location and the tissue excision at the end of trial (histological cure). * Description of the clinical-t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01808950
Start Date
February 1 2013
End Date
August 1 2013
Last Update
June 22 2016
Active Locations (2)
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1
Hauttumorcentrum Charité (HTCC)
Berlin, Germany
2
Universitaetsspital
Zurich, Switzerland