Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
NCT ID: NCT01808950
Last Updated: 2016-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2013-02-28
2013-08-31
Brief Summary
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Detailed Description
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* 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-therapeutic effect of resiquimod on nBCC (nodular-basal cell carcinoma) by visual inspection (clinical evaluation of treatment area and assessment of complete clinical clearance)
* RNA-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals)
* Investigator's global judgment of efficacy by means of a 7-point scale
Safety assessments:
* Evaluation of Adverse Events (AEs) and Serious Adverse Events (SAEs)
* Evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exsudate, dryness, encrustation) by means of symptom scoring scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).
* Evaluation of systemic tolerability \[hematology (erythrocytes, leucocytes including neutrophils, hemoglobin, hematocrit, thrombocytes), blood chemistry (alkaline phosphatase, bilirubin, aspartate transaminase (ASAT), alanine transaminase (ALAT), serum creatinine), vital signs\]. The thresholds concerning laboratory abnormalities that determine patient's discontinuation from trial were predefined upfront.
* Evaluation of the number of patients withdrawn from the trial
* Investigator's global judgment of tolerability by means of a 6-point scale
* Photographic documentation of the treatment area
Exploratory parameter:
* C-reactive protein (CRP)
* Interferon-alpha, interleukin-6, interleukin-12, interferon-gamma, TNF-alpha (up-regulation of gene expression)
* Immunohistochemistry and characterization of cell types (CD8, T-cells, macrophages, dendritic cells)
* In addition, blood serum samples will be preserved and frozen for later tests that will be specified to the patients. The preserved material will be stored for a maximum of 2 years.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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0.06% Resiquimod Gel - A
* 60 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - A
single 60mg dose
0.06% Resiquimod Gel - B
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
0.06% Resiquimod Gel - B
single 100mg dose
0.06% Resiquimod Gel - C
* 100 mg gel
* Once daily prior to normal sleeping hours
* 5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation
* The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed
0.06% Resiquimod Gel - C
shave biopsy of BCC followed by single 100mg dose
Interventions
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0.06% Resiquimod Gel - A
single 60mg dose
0.06% Resiquimod Gel - B
single 100mg dose
0.06% Resiquimod Gel - C
shave biopsy of BCC followed by single 100mg dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Spirig Pharma Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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R Dummer, PrMD
Role: PRINCIPAL_INVESTIGATOR
Clinical Dermatolgy Zurich
Locations
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Hauttumorcentrum Charité (HTCC)
Berlin, , Germany
Universitaetsspital
Zurich, , Switzerland
Countries
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Other Identifiers
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SP848-nBCC-1104
Identifier Type: -
Identifier Source: org_study_id
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