Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell C… (NCT01808950) | Clinical Trial Compass
TerminatedPhase 1/2
Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
Stopped: safety issues
Germany, Switzerland4 participantsStarted 2013-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 star…
What they're measuring
1
Histological Cure Rate
Timeframe: 8 weeks after a maximal treatment period of 4 weeks