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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014