Actinic KeratosisPhase 3NCT00987246
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
A Phase 3 study testing LAS41005 and LAS106521 in people with Actinic Keratosis, run by Almirall, S.A. at 40 sites in Germany.
Trial summary
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- LAS41005 and LAS106521
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 40 sitesGermany
- Study dates
- Jun 2008to Jun 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991
- Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception
Main Exclusion Criteria:
- Have received effective treatment of AK in the three months preceding this clinical trial
- Have known hypersensitivity to LAS41005 or LAS106521
- Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
- Patient's taking phenytoin
- Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Germany40 sites
Almirall Facility Site#37
Altenkirchen, 57610
Almirall Facility Site#24
Augsburg, 86163
Almirall Facility Site#23
Augsburg, 86179
Almirall Facility Site#01
Berlin, 10117
Almirall Facility Site#28
Berlin, 10437
Almirall Facility Site#02
Berlin, 10827
Almirall Facility Site#34
Berlin, 10967
Almirall Facility Site#35
Berlin, 12353
Almirall Facility Site#31
Bonn, 53111
Almirall Facility Site#04
Buxtehude, 21614
Almirall Facility Site#40
Detmold, 32756
Almirall Facility Site#30
Dresden, 01097
Almirall Facility Site#11
Dülmen, 48249
Almirall Facility Site#12
Düsseldorf, 40225
Almirall Facility Site#17
Frankfurt, 60590
Almirall Facility Site#22
Freiburg im Breisgau, 79104
Almirall Facility Site#36
Friedrichshafen, 88045
Almirall Facility Site#19
Fulda, 36037
Almirall Facility Site#32
Göttingen, 37075
Almirall Facility Site#09
Hamburg, 20148
Almirall Facility Site#10
Hansestadt Salzwedel, 29410
Almirall Facility Site#29
Jena, 07740
Almirall Facility Site#07
Kiel, 24103
Almirall Facility Site#08
Kiel, 24105
Almirall Facility Site#15
Koblenz, 56068
Almirall Facility Site#21
Landau, 76829
Almirall Facility Site#27
Leipzig, 04103
Almirall Facility Site#06
Lübeck, 23538
Almirall Facility Site#03
Mahlow, 15831
Almirall Facility Site#25
München, 80337
Almirall Facility Site#39
München, 81476
Almirall Facility Site#33
Nördlingen, 86720
Almirall Facility Site#38
Osnabrück, 49078
Almirall Facility Site#05
Pinneberg, 25421
Almirall Facility Site#26
Quedlinburg, 06484
Almirall Facility Site#20
Radolfzell, 78315
Almirall Facility Site#16
Soest, 59494
Almirall Facility Site#14
Vechta, 49377
Almirall Facility Site#18
Wiesbaden, 65191
Almirall Facility Site#13
Wuppertal, 42275
About this study
Official title: Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
Read the detailed description
To investigate as primary objective:
- Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;
To investigate as secondary objective:
- Superiority to LAS106521
- Improvement of treated lesions (lesion response)
- Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
- Patient's assessment of tolerability and efficacy and patient's compliance
- Conditions
- Actinic Keratosis
- Being tested
- Placebo Gel, LAS41005, LAS106521
- Keywords
- Actinic Keratosis, AK, NMSC, Combination
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GelDrug
Topical
LAS41005Drug
Topical
LAS106521Drug
Topical
| Study group | Role | What they receive |
|---|---|---|
| LAS41005 | Experimental | Not described Receives: Drug: LAS41005 |
| LAS106521 | Active comparator | Not described Receives: Drug: LAS106521 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological status of AK target lesion
Measured: Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Estrella Garcia, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987246
- Sponsor's protocol ID
- H 1005 6002 - 0702
- Other IDs
- EudraCT: 2007-003889-18
- Status last verified
- Jul 2015
- First submitted
- 29 Sep 2009
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
- ClinicalTrials.gov ID
- NCT00987246
- Acronym / sponsor ID
- H 1005 6002 - 0702
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, AK, NMSC, Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2009 (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 purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
Detailed description
To investigate as primary objective:
- Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;
To investigate as secondary objective:
- Superiority to LAS106521
- Improvement of treated lesions (lesion response)
- Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
- Patient's assessment of tolerability and efficacy and patient's compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LAS41005 | Experimental | Drug: LAS41005 |
| LAS106521 | Active comparator | Drug: LAS106521 |
| Placebo | Placebo comparator | Drug: Placebo Gel |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Placebo GelTopical | Drug | Placebo |
| LAS41005Topical | Drug | LAS41005 |
| LAS106521Topical | Drug | LAS106521 |
Primary outcome
Histological status of AK target lesion
Time frame: Day 140
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 28 Jul 2015.
- Sponsor websiteLink 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.
Estrella Garcia, MD, MBA study director
Almirall Hermal GmbH
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LAS41005 and LAS106521 in people with Actinic Keratosis, run by Almirall, S.A. at 40 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites 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?
Histological status of AK target lesion (time frame: Day 140). 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 28 Jul 2015.