Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Spirig Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT01808950
First received: March 5, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Nodular Basal Cell Carcinoma
Drug: 0.06% Resiquimod Gel - A
Drug: 0.06% Resiquimod Gel - B
Drug: 0.06% Resiquimod Gel - C
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)

Further study details as provided by Spirig Pharma Ltd.:

Primary Outcome Measures:
  • Histological cure rate [ Time Frame: 8 weeks after a maximal treatment period of 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global judgment of efficacy (by investigator) by means of a 7-point scale [ Time Frame: 8 weeks after a maximal treatment period of 4 weeks ] [ Designated as safety issue: No ]
  • Evaluation of local tolerability by means of 5-point scales [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
    local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged 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 [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Global judgment of tolerability by investigator by means of a 6-point scale [ Time Frame: 8 weeks after a maximal treatment period of 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 0.06% Resiquimod Gel - A
Experimental: 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
Drug: 0.06% Resiquimod Gel - B
Experimental: 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
Drug: 0.06% Resiquimod Gel - C

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808950

Locations
Germany
Hauttumorcentrum Charité (HTCC)
Berlin, Germany
Switzerland
Universitaetsspital
Zurich, Switzerland
Sponsors and Collaborators
Spirig Pharma Ltd.
  More Information

No publications provided

Responsible Party: Spirig Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01808950     History of Changes
Other Study ID Numbers: SP848-nBCC-1104
Study First Received: March 5, 2013
Last Updated: October 24, 2013
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on April 17, 2014