Actinic KeratosisPhase 3NCT01265602
Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis
A Phase 3 study testing LAS41007 and LASW1510 in people with Actinic Keratosis, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK). 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?
- LAS41007 and LASW1510
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 889 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Mar 2012
- Phase
- Phase 3
- 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
- Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp,
- The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm,
- The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm,
- The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2),
- Diagnosis of AK histologically confirmed
Who cannot join
- Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs and other non-steroidal anti-inflammatory agents,
- Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of non-steroidal anti-inflammatory drugs (NSAIDs),
- Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs,
- Have evidence of clinically significant or unstable medical conditions,
- Have currently and within the past 3 months other malignant tumors of the skin in the TAs,
- Suffer from paresthesia in the TAs,
Show all 25Show fewer
- Show cornu cutaneum of the skin and/or hypertrophic AK lesions in the TAs,
- Are known to be pregnant or lactating (currently or within the past 3 months),
- Any clinically relevant abnormal finding during Screening and/or Baseline,
- Specific topical treatments in the target area within defined time periods.
- Specific physical treatments in the TAs within defined time periods.
- Specific systemic treatments within defined time periods.
- Patients suffering from AK in locations other than the target areas, receiving any topical AK-therapy throughout the interventional phase of the study until termination of V6,
- Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as "prn" (pro re nata), i.e. to be taken as needed (≤ 3 days at a stretch) and the use of ASA as anticoagulative therapy will be allowed,
- Patients taking methotrexate or sulfonylurea during the interventional phase of the study,
- Anticoagulative therapy, e.g. with cumarines or heparines throughout the interventional phase of the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed,
- Patients having any significant physical abnormalities in the potential TAs that may cause difficulty with examination or final evaluation,
- Have any dermatological disease in the TAs or surrounding area that may be exacerbated by treatment with topical diclofenac or cause difficulty with examination,
- Physical or mental inability and/or unwillingness to apply the study preparations correctly and to follow the study restrictions and visits,
- Any suspicion of current drug and/or alcohol abuse as assessed by the investigator,
- Anticipated non-availability for study visits / procedures,
- Exposure to an investigational product within the last 3 months,
- Any previous randomization into this trial,
- Patient is institutionalized because of legal or regulatory order,
- Employee of the study site or of the Sponsor's company or the CRO.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).
- Conditions
- Actinic Keratosis
- Being tested
- LAS41007, LASW1510, vehicle of LAS41007
- Keywords
- Actinic Keratosis, AK, NMSC
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS41007Drug
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
LASW1510Drug
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
vehicle of LAS41007Drug
Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
| Study group | Role | What they receive |
|---|---|---|
| LAS41007 | Experimental | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. Receives: Drug: LAS41007 |
| LASW1510 | Active comparator | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. Receives: Drug: LASW1510 |
| vehicle | Placebo comparator | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. Receives: Drug: vehicle of LAS41007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
superiority of LAS41007 compared to vehicle
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
Measured: Day 1
superiority of LAS41007 compared to vehicle
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
Measured: Day 150
Secondary outcomes (5)
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Measured: Day 1
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Measured: Day 21
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Measured: Day 56
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Measured: Day 90
superiority of LAS41007 compared to vehicle
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
Measured: Day 150
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2012
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.
- More trials run by Almirall, S.A.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Estrella Estrella Garcia, PhD, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265602
- Sponsor's protocol ID
- H 569 000 - 1004
- Status last verified
- Jul 2012
- First submitted
- 21 Dec 2010
- Last updated
- 24 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01265602
- Acronym / sponsor ID
- H 569 000 - 1004
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, AK, NMSC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Dec 2010 (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.
The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAS41007 | Experimental | Drug: LAS41007All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
| LASW1510 | Active comparator | Drug: LASW1510All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
| vehicle | Placebo comparator | Drug: vehicle of LAS41007All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have at least 6 but not more than 16 clinically confirmed AK target lesions of mild to moderate (grade I to II, according to Olsen et al., 1991) intensity in the whole treatment area (TA) (and additionally one representative AK lesion for histological diagnosis of AK), which must be located in the face including the forehead (excluding eyelids, lips and mucosa) and/or bald scalp,
- The AK target lesions must be discrete and quantifiable; the distance from one lesion to its neighbor lesion must be greater than 1.0 cm,
- The diameter of each AK target lesion should be not less than 0.5 cm and not greater than 1.5 cm,
- The target lesions must be located in up to 3 TAs with a size of 25 cm2 per TA (i.e. total area of TA is up to 75 cm2),
- Diagnosis of AK histologically confirmed
Key exclusion criteria (25 listed)
- Have known hypersensitivity, intolerance or allergies against ingredients of the IMPs and other non-steroidal anti-inflammatory agents,
- Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of non-steroidal anti-inflammatory drugs (NSAIDs),
- Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs,
- Have evidence of clinically significant or unstable medical conditions,
- Have currently and within the past 3 months other malignant tumors of the skin in the TAs,
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 |
|---|---|---|
| LAS41007Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². | Drug | LAS41007 |
| LASW1510Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². | Drug | LASW1510 |
| vehicle of LAS41007Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². | Drug | vehicle |
Primary outcome
superiority of LAS41007 compared to vehicle
Time frame: Day 1
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
superiority of LAS41007 compared to vehicle
Time frame: Day 150
superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion
5 secondary outcomes
superiority of LAS41007 compared to vehicle
Time frame: Day 1
superiority of LAS41007 compared to vehicle
Time frame: Day 21
superiority of LAS41007 compared to vehicle
Time frame: Day 56
superiority of LAS41007 compared to vehicle
Time frame: Day 90
superiority of LAS41007 compared to vehicle
Time frame: Day 150
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 24 Jul 2012.
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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.
Dr. Estrella Estrella Garcia, PhD study director
Almirall, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LAS41007 and LASW1510 in people with Actinic Keratosis, run by Almirall, S.A. at 1 site in Germany.
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 25 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 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
superiority of LAS41007 compared to vehicle (time frame: Day 1). The study lists 2 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 24 Jul 2012.