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

NCT ID: NCT01808950

Last Updated: 2016-06-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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efficacy assessments:

* Histopathological findings based on the biopsies of the primary tumor location and the tissue excision at the end of trial (histological cure).
* Description of the clinical-therapeutic effect of resiquimod on nBCC (nodular-basal cell carcinoma) by visual inspection (clinical evaluation of treatment area and assessment of complete clinical clearance)
* RNA-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals)
* Investigator's global judgment of efficacy by means of a 7-point scale

Safety assessments:

* Evaluation of Adverse Events (AEs) and Serious Adverse Events (SAEs)
* Evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exsudate, dryness, encrustation) by means of symptom scoring scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).
* Evaluation of systemic tolerability \[hematology (erythrocytes, leucocytes including neutrophils, hemoglobin, hematocrit, thrombocytes), blood chemistry (alkaline phosphatase, bilirubin, aspartate transaminase (ASAT), alanine transaminase (ALAT), serum creatinine), vital signs\]. The thresholds concerning laboratory abnormalities that determine patient's discontinuation from trial were predefined upfront.
* Evaluation of the number of patients withdrawn from the trial
* Investigator's global judgment of tolerability by means of a 6-point scale
* Photographic documentation of the treatment area

Exploratory parameter:

* C-reactive protein (CRP)
* Interferon-alpha, interleukin-6, interleukin-12, interferon-gamma, TNF-alpha (up-regulation of gene expression)
* Immunohistochemistry and characterization of cell types (CD8, T-cells, macrophages, dendritic cells)
* In addition, blood serum samples will be preserved and frozen for later tests that will be specified to the patients. The preserved material will be stored for a maximum of 2 years.

Conditions

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Nodular Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

0.06% Resiquimod Gel - A

Intervention Type DRUG

single 60mg dose

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

Group Type EXPERIMENTAL

0.06% Resiquimod Gel - B

Intervention Type DRUG

single 100mg dose

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

Group Type EXPERIMENTAL

0.06% Resiquimod Gel - C

Intervention Type DRUG

shave biopsy of BCC followed by single 100mg dose

Interventions

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0.06% Resiquimod Gel - A

single 60mg dose

Intervention Type DRUG

0.06% Resiquimod Gel - B

single 100mg dose

Intervention Type DRUG

0.06% Resiquimod Gel - C

shave biopsy of BCC followed by single 100mg dose

Intervention Type DRUG

Other Intervention Names

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CD11301 CD11301 CD11301

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spirig Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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R Dummer, PrMD

Role: PRINCIPAL_INVESTIGATOR

Clinical Dermatolgy Zurich

Locations

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Hauttumorcentrum Charité (HTCC)

Berlin, , Germany

Site Status

Universitaetsspital

Zurich, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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SP848-nBCC-1104

Identifier Type: -

Identifier Source: org_study_id

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