Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma

NCT01808950 | Terminated Phase 1 Results

• 1 other identifier: SP848-nBCC-1104
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Nodular Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Histological Cure Rate

  8 weeks after a maximal treatment period of 4 weeks

Secondary Outcomes (4)

• Complete Clinical Clearance Rate

  8 weeks after the 4 weeks treatment period

• Evaluation of Local Tolerability by Means of 5-point Scales

  up to 12 weeks

• Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs

  up to 12 weeks

• Global Judgment of Tolerability by Investigator by Means of a 6-point Scale

  8 weeks after a maximal treatment period of 4 weeks

Study Arms (3)

0.06% Resiquimod Gel - A

EXPERIMENTAL

* 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

0.06% Resiquimod Gel - B

EXPERIMENTAL

* 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

0.06% Resiquimod Gel - C

EXPERIMENTAL

* 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

Interventions

0.06% Resiquimod Gel - A DRUG

single 60mg dose

Also known as: CD11301

0.06% Resiquimod Gel - A

0.06% Resiquimod Gel - B DRUG

single 100mg dose

Also known as: CD11301

0.06% Resiquimod Gel - B

0.06% Resiquimod Gel - C DRUG

shave biopsy of BCC followed by single 100mg dose

Also known as: CD11301

0.06% Resiquimod Gel - C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spirig Pharma Ltd.: lead

Study Sites (2)

Hauttumorcentrum Charité (HTCC)

Berlin, Germany

Location

Universitaetsspital

Zurich, Switzerland

Location

Results Point of Contact

• Title: Dr. Francine Santoro
• Organization: Galderma Spirig

francine.santoro@galderma.com

+41623878720

Study Officials

• R Dummer, PrMD

  Clinical Dermatolgy Zurich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 11, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 22, 2016
• Results First Posted: June 22, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); DE (1)