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

Nodular Basal Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01808950
• Other study ID #: SP848-nBCC-1104
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 5, 2013
• Last updated: October 24, 2013
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2013
• Source: Spirig Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Nodular Basal Cell Carcinoma

Intervention

Drug:
• 0.06% Resiquimod Gel - A

• 0.06% Resiquimod Gel - B

• 0.06% Resiquimod Gel - C

Locations

Country	Name	City	State
Germany	Hauttumorcentrum Charité (HTCC)	Berlin
Switzerland	Universitaetsspital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Spirig Pharma Ltd.

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological cure rate		8 weeks after a maximal treatment period of 4 weeks	No
Secondary	Global judgment of efficacy (by investigator) by means of a 7-point scale		8 weeks after a maximal treatment period of 4 weeks	No
Secondary	Evaluation of local tolerability by means of 5-point scales	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).	up to 12 weeks	Yes
Secondary	Evaluation of systemic tolerability based on haematology and blood chemistry values and vital signs		up to 12 weeks	Yes
Secondary	Global judgment of tolerability by investigator by means of a 6-point scale		8 weeks after a maximal treatment period of 4 weeks	Yes