Actinic KeratosisNCT01806961
Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
An observational study of Actinic Keratosis, run by Spirig Pharma Ltd. at 9 sites in 2 countries.
Trial summary
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- How many people
- 16 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2013to Sep 2013
- Phase
- Observational
- 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
Study population: Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non- Responder who withdrew from the trial prematurely.
Who may be able to join
- Signed informed consent.
- Participation in the previous clinical trial SP848-AK-1101.
- Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.
Who cannot join
- Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
- Evidence of systemic cancer.
- Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
Trial locations and contacts
9 sites in 2 countries.
9 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
Switzerland4 sites
Universitätsspital Basel
Basel
Inselspital
Bern
Kantonsspital St.Gallen
Sankt Gallen
Universitaetsspital Zurich
Zurich
About this study
Official title: Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.
Read the detailed description
Efficacy Evaluation:
- Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.
Safety Evaluation:
- Evaluation of adverse events (AEs) and serious adverse events (SAEs)
- Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).
- Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.
- Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.
- Conditions
- Actinic Keratosis
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| clearance at end of trial SP848-AK-1101 | no trial medication during this follow-up trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Recurrence Rate of AK-lesions
Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.
Measured: at 6 and 12 months
Secondary outcomes (2)
Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)
clinical examination
Measured: at 6 and 12 months
Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area
recording of adverse events
Measured: at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionSep 2013
Why it stopped: sponsor decision
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 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
- NCT01806961
- Sponsor's protocol ID
- SP848-AKEx-1209
- Status last verified
- May 2016
- First submitted
- 6 Mar 2013
- Last updated
- 3 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT01806961
- Acronym / sponsor ID
- SP848-AKEx-1209
- Conditions
- Actinic Keratosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Spirig Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.
Detailed description
Efficacy Evaluation:
- Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions.
Safety Evaluation:
- Evaluation of adverse events (AEs) and serious adverse events (SAEs)
- Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability).
- Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101.
- Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clearance at end of trial SP848-AK-1101 | – | –no trial medication during this follow-up trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non- Responder who withdrew from the trial prematurely.
Key inclusion criteria (3 listed)
- Signed informed consent.
- Participation in the previous clinical trial SP848-AK-1101.
- Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.
Key exclusion criteria (3 listed)
- Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases).
- Evidence of systemic cancer.
- Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the Recurrence Rate of AK-lesions
Time frame: at 6 and 12 months
Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.
2 secondary outcomes
Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)
Time frame: at 6 and 12 months
Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area
Time frame: at 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratosis, run by Spirig Pharma Ltd. at 9 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 3 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: stopped early, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 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?
Determine the Recurrence Rate of AK-lesions (time frame: at 6 and 12 months). 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 3 Aug 2016.