Actinic KeratosisPhase 2NCT02404389
Safety, Tolerability, and Efficacy Study of LFX453 in Actinic Keratosis Patients
A Phase 2 study testing Investigational Treatment and Active comparator in people with Actinic Keratosis, run by Novartis Pharmaceuticals at 10 sites in 5 countries.
Trial summary
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Investigational Treatment and Active comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 5 Mar 2015to 27 Jan 2016
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Patients with at least five clinically typical, visible or palpable non-hyperkeratotic AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears) and/or balding scalp
- Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment
- Male patients had to agree to use adequate contraception for the duration of the study.
Who cannot join
- Known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction.
- Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
- Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if completely surgically removed.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- History of hypertrophic scarring.
- Concurrent disease that suppresses the immune system.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany6 sites
Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Bonn, 53111
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Hamburg, 20354
About this study
Official title: A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
- Conditions
- Actinic Keratosis
- Being tested
- Investigational Treatment, Active comparator
- Keywords
- Actinic keratosis, patients, topical, lesion count, clearance rate
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational TreatmentDrug
Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
Active comparatorDrug
Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
| Study group | Role | What they receive |
|---|---|---|
| LFX453 0.1% NMC | Experimental | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications Receives: Drug: Investigational Treatment |
| LFX453 0.15% LCC | Experimental | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications Receives: Drug: Investigational Treatment |
| Vehicle to NMC | Placebo comparator | Vehicle to nanomedicinal cream (NMC) Twice daily applications Receives: Drug: Investigational Treatment |
| Vehicle to LCC | Placebo comparator | Vehicle to liquid crystal cream (LCC) Twice daily applications Receives: Drug: Investigational Treatment |
| Aldara | Active comparator | Aldara cream 3 applications per week Receives: Drug: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks
Number of participants with at least one AE/SAE in the category up to 20 weeks
Measured: 20 weeks
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Measured: Week 20
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Measured: Baseline, Week 20
Secondary outcomes (4)
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
Measured: week 8, week 16
Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined
Measured: Week 20
Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined
Measured: week 8, week 16
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined
Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start5 Mar 2015
- Primary completion27 Jan 2016
- Study completion27 Jan 2016
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404389
- Sponsor's protocol ID
- CLFX453X2201
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2015
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Topical LFX453 Formulations in Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02404389
- Acronym / sponsor ID
- CLFX453X2201
- Conditions
- Actinic Keratosis
- Keywords
- Actinic keratosis, patients, topical, lesion count, clearance rate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 27 Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. Study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. Assessors of study endpoints are blinded to treatment allocation.
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 |
|---|---|---|
| LFX453 0.1% NMC | Experimental | Drug: Investigational TreatmentLFX453 0.1% nanomedicinal cream (NMC) Twice daily applications |
| LFX453 0.15% LCC | Experimental | Drug: Investigational TreatmentLFX453 0.15% liquid crystal cream (LCC) Twice daily applications |
| Vehicle to NMC | Placebo comparator | Drug: Investigational TreatmentVehicle to nanomedicinal cream (NMC) Twice daily applications |
| Vehicle to LCC | Placebo comparator | Drug: Investigational TreatmentVehicle to liquid crystal cream (LCC) Twice daily applications |
| Aldara | Active comparator | Drug: Active comparatorAldara cream 3 applications per week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
- Patients with at least five clinically typical, visible or palpable non-hyperkeratotic AK lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears) and/or balding scalp
- Presence of at least one additional visible or palpable non hyperkeratotic AK lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment
- Male patients had to agree to use adequate contraception for the duration of the study.
Key exclusion criteria (6 listed)
- Known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction.
- Presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area.
- Invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (SCC), basal cell carcinoma, the latter being accepted if completely surgically removed.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- History of hypertrophic scarring.
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 |
|---|---|---|
| Investigational TreatmentTopical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up. | Drug | LFX453 0.1% NMC, LFX453 0.15% LCC, Vehicle to LCC, Vehicle to NMC |
| Active comparatorTopical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up. | Drug | Aldara |
Primary outcome
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks
Time frame: 20 weeks
Number of participants with at least one AE/SAE in the category up to 20 weeks
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Time frame: Week 20
Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Time frame: Baseline, Week 20
Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined
4 secondary outcomes
Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Time frame: week 8, week 16
Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined
Time frame: Week 20
Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined
Time frame: week 8, week 16
Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Treatment and Active comparator in people with Actinic Keratosis, run by Novartis Pharmaceuticals at 10 sites in 5 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 6 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 5 Jan 2021. 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, Austria, Denmark, Iceland, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2018). 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?
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks (time frame: 20 weeks). The study lists 3 primary outcomes in all. 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 5 Jan 2021.