Nodular Basal Cell Carcinoma MedDRA version: 14.1 Level: PT Classification code 10004146 Term: Basal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Resiquimod Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Resiquimod
CAS Number: 144875-48-9
Current Sponsor code: R-848
Other descriptive name: S-28463, VML600
Concentration unit: %
Sponsors
Spirig Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed consent form. • Male or non-pregnant, non-lactating female, = 18 years. For women of childbearing potential the use of highly effective methods of birth control (precautions to prevent pregnancy) is mandatory. Highly effective methods of birth control are defined as those, alone or in combination, which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly – such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. In this trial women of childbearing potential are instructed to use oral contraceptives or IUDs in combination with a barrier device (e.g. condom). • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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. Treatments before the start of the trial (restrictions): Local/topical treatments in the treatment area: • Photodynamic treatment or 5-Fluorouracil (5-FU) within 2 weeks of the start of the trial. • Laser treatment, cryotherapy or surgical treatment within 4 weeks of trial entry. • Imiquimod, topical corticosteroids or topical retinoids within 8 weeks of trial entry. Systemic treatments: • High-dose vitamin A (> 15’000 units per day) within 2 weeks of trial entry. • Immunomodulatory or cytotoxic treatments, systemic (> 10 mg/day) or high-dosed inhaled (> 1600 ?g/day) corticosteroids within 4 weeks of trial entry. • Interferon/interferon-inducers or immunosuppressors within 8 weeks of trial entry • Chemotherapy, radiation therapy or systemic retinoids, treatment with UVB or psoralens with UVA within 6 months of trial entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objectives are the (1) Observation and description of the systemic safety of resiquimod gel 0.06% in patients with nBCC. (2) Observation and description of the local tolerability of resiquimod gel 0.06% in patients with nBCC. (3) Analysis of gene expressions for inflammatory signals.;Primary end point(s): Efficacy: Histological cure rate at the end of trial. ;Timepoint(s) of evaluation of this end point: • At the end of trial • At the biological endpoint (skin erosion/encrustation) plus 56 days (8 weeks) follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: • Complete clinical clearance rate (number of patients with clinical clearance according to investigator’s assessment). • Global judgment of efficacy (by investigator) by means of a 7-point scale. • RNA-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals) Safety: • Evaluation of adverse events (AEs) and serious adverse events (SAEs). • Evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation) by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe). • Evaluation of systemic tolerability (based on haematology and blood chemistry values and vital signs). • Number of patients withdrawn from trial. • Global judgment of tolerability (by investigator) by means of a 6-point scale. • Photographic documentation of the treatment area;Timepoint(s) of evaluation of this end point: At day 1 of treatment, day 5 of treatment, end of treatment, at mid-term of follow-up and at end of trial (EOT): • Evaluation of systemic tolerability • Photographic documentation of the treatment area At day 5 of treatment, end of treatment, at mid-term of follow-up and at EOT: • Evaluation of local tolerability by investigator At day 5 of treatment and at EOT: • RNA analysis Ongoing: • Evaluation of adverse events (AEs) and serious adverse events (SAEs) • Number of patients withdrawn from trial. At EOT: • Complete clinical clearance rate (number of patients with clinical clearance according to investigator’s assessment) • Global judgment of efficacy (by investigator) • Global judgment of tolerability (by investigator) | — |
Countries
Germany, Switzerland
Contacts
Public ContactInfo Contact
Spirig Pharma AG
Outcome results
None listed