Nodular Basal Cell CarcinomaPhase 1/2NCT01808950
Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma
A Phase 1/2 study testing 0.06% Resiquimod Gel - A, 0.06% Resiquimod Gel - B and 0.06% Resiquimod Gel - C in people with Nodular Basal Cell Carcinoma, run by Spirig Pharma Ltd. at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular Basal Cell Carcinoma
- What is being tested?
- 0.06% Resiquimod Gel - A, 0.06% Resiquimod Gel - B and 0.06% Resiquimod Gel - C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2013to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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)
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.
Read the detailed description
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
- Nodular Basal Cell Carcinoma
- Being tested
- 0.06% Resiquimod Gel - A, 0.06% Resiquimod Gel - B, 0.06% Resiquimod Gel - C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.06% Resiquimod Gel - ADrug
Also called CD11301
single 60mg dose
0.06% Resiquimod Gel - BDrug
Also called CD11301
single 100mg dose
0.06% Resiquimod Gel - CDrug
Also called CD11301
shave biopsy of BCC followed by single 100mg dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: 0.06% Resiquimod Gel - C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Cure Rate
Measured: 8 weeks after a maximal treatment period of 4 weeks
Secondary outcomes (4)
Complete Clinical Clearance Rate
Measured: 8 weeks after the 4 weeks treatment period
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).
Measured: up to 12 weeks
Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs
Measured: up to 12 weeks
Global Judgment of Tolerability by Investigator by Means of a 6-point Scale
Measured: 8 weeks after a maximal treatment period of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: safety issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nodular Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirig Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Dummer, PrMD, Principal investigator, Clinical Dermatolgy Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808950
- Sponsor's protocol ID
- SP848-nBCC-1104
- Status last verified
- May 2016
- First submitted
- 5 Mar 2013
- Last updated
- 22 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01808950
- Acronym / sponsor ID
- SP848-nBCC-1104
- Conditions
- Nodular Basal Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety issues
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Spirig Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 22 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.06% Resiquimod Gel - A | Experimental | Drug: 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 |
| 0.06% Resiquimod Gel - B | Experimental | Drug: 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 |
| 0.06% Resiquimod Gel - C | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.06% Resiquimod Gel - AAlso: CD11301single 60mg dose | Drug | 0.06% Resiquimod Gel - A |
| 0.06% Resiquimod Gel - BAlso: CD11301single 100mg dose | Drug | 0.06% Resiquimod Gel - B |
| 0.06% Resiquimod Gel - CAlso: CD11301shave biopsy of BCC followed by single 100mg dose | Drug | 0.06% Resiquimod Gel - C |
Primary outcome
Histological Cure Rate
Time frame: 8 weeks after a maximal treatment period of 4 weeks
4 secondary outcomes
Complete Clinical Clearance Rate
Time frame: 8 weeks after the 4 weeks treatment period
Evaluation of Local Tolerability by Means of 5-point Scales
Time frame: up to 12 weeks
Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs
Time frame: up to 12 weeks
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Dummer, PrMD principal investigator
Clinical Dermatolgy Zurich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.06% Resiquimod Gel - A, 0.06% Resiquimod Gel - B and 0.06% Resiquimod Gel - C in people with Nodular Basal Cell Carcinoma, run by Spirig Pharma Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Cure Rate (time frame: 8 weeks after a maximal treatment period of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.