Actinic KeratosisPhase 2NCT01583816
Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions
A Phase 2 study testing Resiquimod 0.03% and Resiquimod 0.01% in people with Actinic Keratosis, run by Spirig Pharma Ltd. at 10 sites in 2 countries.
Trial summary
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Resiquimod 0.03% and Resiquimod 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 10 sitesin 2 countries
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 informed consent
- Male or nonpregnant, nonlactating female, ≥18 years
- A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion)
- AK-lesions on balding scalp, forehead or face
Who cannot join
- Known allergy or hypersensitivity to any of the trial gel ingredients
- Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments
- Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany5 sites
Hauttumorcentrum Charité (HTCC)
Berlin
Medizinisches Zentrum Bonn - Friedensplatz
Bonn
Hautzentrum
Düsseldorf
Johannes Wesling Klinikum Minden
Minden
KLINIKUM VEST GmbH Knappschaftskrankenhaus
Recklinghausen
Switzerland5 sites
Kantonsspital Aarau
Aarau
Universitätsspital Basel
Basel
Inselspital
Bern
Kantonsspital St.Gallen
Sankt Gallen
Universitaetsspital Zurich
Zurich
About this study
Official title: Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
Read the detailed description
Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla):
Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo).
Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).
- Conditions
- Actinic Keratosis
- Being tested
- Resiquimod 0.03%, Resiquimod 0.01%, placebo
- Keywords
- Actinic Keratosis, Resiquimod
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resiquimod 0.03%Drug
topical application
Resiquimod 0.01%Drug
topical application
placeboDrug
topical application
| Study group | Role | What they receive |
|---|---|---|
| Resiquimod Gel 0.03% or placebo | Experimental | Resiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once Receives: Drug: Resiquimod 0.03%; Drug: placebo |
| Resiquimod or placebo | Experimental | Once daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once Receives: Drug: Resiquimod 0.03%; Drug: placebo |
| Resiquimod or vehicle | Experimental | Once daily, 5x for 1 week, break of 8 weeks, cycle repeated once Receives: Drug: Resiquimod 0.03%; Drug: placebo |
| Resiquimod gel 0.01% | Experimental | Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up Receives: Drug: Resiquimod 0.01% |
| Resiquimod gel 0.03% | Experimental | Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up Receives: Drug: Resiquimod 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with complete clinical clearance in the treated area at the end of trial
Measured: 8 weeks after a maximal treatment period of 8 weeks
Secondary outcomes (4)
Evaluation of adverse events (AEs) and serious adverse events (SAEs)
Measured: up to 24 weeks
Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales
Measured: up to 24 weeks
Number of patients with partial clearance
Measured: 8 weeks after a maximal treatment period of 8 weeks
Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spirig Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars E French, MD, Principal investigator, University Clinic of Dermatology, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583816
- Sponsor's protocol ID
- SP848-AK-1101
- Status last verified
- Dec 2015
- First submitted
- 18 Apr 2012
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Partly Blinded, in Part Placebo-controlled, Multicenter, Dose-finding Trial Exploring Safety, Tolerability and Efficacy of a Topical Resiquimod Gel in Patients With Multiple Actinic Keratosis Lesions
- ClinicalTrials.gov ID
- NCT01583816
- Acronym / sponsor ID
- SP848-AK-1101
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Resiquimod
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Spirig Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Dose-Finding Study of Resiquimod Evaluating Safety and Efficacy in Patients with Multiple Actinic Keratosis Lesions
Detailed description
Prospective, randomized, partly blinded, in part placebo-controlled, multicenter dose-finding trial with patients suffering from AK. Patients were observed for efficacy, local tolerability and safety. A total of 14 sites in Switzerland and Germany enrolled male and female patients over 18 years of age with clinically diagnosed AK lesions Patients were randomized to receive resiquimod gel (Treatment Arms 1, 2, 3, 4, or 5) or matching vehicle (Treatment Arms 1-Pla, 2-Pla, or 3-Pla):
Treatment Arms 1, 2 and 3: The patient was randomly assigned to one of three treatment groups and within each group there was one randomly assigned placebo patient for every two treatment patients (parallel-group randomization; 2:1 active vs placebo).
Treatment Arms 4 and 5: The patient was randomly assigned to one of two treatment groups (parallel-group randomization, 1:1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Resiquimod Gel 0.03% or placebo | Experimental | Drug: Resiquimod 0.03%, Drug: placeboResiquimod gel 0.03% or placebo, once daily, 3x per week for 4 weeks, break of 8 weeks, repeated once |
| Resiquimod or placebo | Experimental | Drug: Resiquimod 0.03%, Drug: placeboOnce daily, 7x within 2 weeks, break of 8 weeks, cycle repeated once |
| Resiquimod or vehicle | Experimental | Drug: Resiquimod 0.03%, Drug: placeboOnce daily, 5x for 1 week, break of 8 weeks, cycle repeated once |
| Resiquimod gel 0.01% | Experimental | Drug: Resiquimod 0.01%Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up |
| Resiquimod gel 0.03% | Experimental | Drug: Resiquimod 0.03%Once daily, 3x/week until occurrence of biological endpoint or for a maximum of 8 weeks (no repetition of cycle), 8 weeks follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Male or nonpregnant, nonlactating female, ≥18 years
- A minimum of 2 clinically diagnosed AK-lesions within a defined area (25 cm2 contiguous treatment area). One AK-lesion must have a diameter of at least 6 mm (indicator lesion)
- AK-lesions on balding scalp, forehead or face
Key exclusion criteria (3 listed)
- Known allergy or hypersensitivity to any of the trial gel ingredients
- Dermatological disease or condition that might be exacerbated by resiquimod gel treatment or may impair trial assessments
- Evidence of unstable or uncontrolled clinically significant medical conditions, active infection, immunosuppression or systemic cancer
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 |
|---|---|---|
| Resiquimod 0.03%topical application | Drug | Resiquimod Gel 0.03% or placebo, Resiquimod gel 0.03%, Resiquimod or placebo, Resiquimod or vehicle |
| Resiquimod 0.01%topical application | Drug | Resiquimod gel 0.01% |
| placebotopical application | Drug | Resiquimod Gel 0.03% or placebo, Resiquimod or placebo, Resiquimod or vehicle |
Primary outcome
Number of patients with complete clinical clearance in the treated area at the end of trial
Time frame: 8 weeks after a maximal treatment period of 8 weeks
4 secondary outcomes
Evaluation of adverse events (AEs) and serious adverse events (SAEs)
Time frame: up to 24 weeks
Evaluation of local tolerability (burning, itching, sensation of pain) by means of symptom scoring scales
Time frame: up to 24 weeks
Number of patients with partial clearance
Time frame: 8 weeks after a maximal treatment period of 8 weeks
Evaluation of systemic tolerability [hematology, blood chemistry, vital signs]
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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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.
Lars E French, MD principal investigator
University Clinic of Dermatology, Zurich
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resiquimod 0.03% and Resiquimod 0.01% in people with Actinic Keratosis, run by Spirig Pharma Ltd. at 10 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with complete clinical clearance in the treated area at the end of trial (time frame: 8 weeks after a maximal treatment period of 8 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 15 Dec 2015.