Actinic KeratosisPhase 2NCT01358851
LAS41005 in Hyperkeratotic Actinic Keratosis
A Phase 2 study testing Cryotherapy and LAS41005 in people with Actinic Keratosis, run by Almirall, S.A. at 4 sites in Germany.
Trial summary
The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies). 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?
- Cryotherapy and LAS41005
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 4 sitesGermany
- Study dates
- Apr 2011to Aug 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Signed and dated written informed consent.
- Men and women aged between 18 and 85 years inclusive.
- Have a general good and stable health condition as confirmed by a physical examination and by medical history.
- Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp
- Skin type I to IV according to Fitzpatrick's .
- Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
- Physical ability to apply the study preparation correctly and to follow the study restrictions and visit.
- Women 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 treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
- Have known hypersensitivity to the ingredients
- Are subjects under immunosuppressive therapy.
- Having coagulation defects which are inherited or acquired
- Have evidence of clinically significant, unstable medical conditions
- Have currently other malignant or benign tumors of the skin within the treatment area
- Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea.
- Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
- Are known to be pregnant or lactating (currently or within the past 3 months).
- Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment
- Are currently or within the past 8 weeks participating in another clinical study.
- Have active chemical dependency or alcoholism as assessed by the investigator.
- Subject is institutionalized because of legal or regulatory order.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Almirall investigative site 3
Dülmen, 48249
Almirall investigative site 1
Leipzig, 04107
Almirall investigative site 4
Soest, 59494
Almirall investigative site 2
Wuppertal, 42275
About this study
Official title: A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis
The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).
- Conditions
- Actinic Keratosis
- Being tested
- Cryotherapy, LAS41005
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
1-2 times during the treatment time
LAS41005Drug
once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug Las41005 Receives: Drug: LAS41005 |
| 2 | Other | Cryotherapy Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological status (AK diagnosis and grade) of one predefined target lesion
Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.
Measured: Screening and 8 weeks after last treatment
Secondary outcomes (1)
Total Actinic keratoses (AK)lesion count at each visit
The clearance rate (complete/partial) of AK lesions (determined by clinical evaluation) in the treatment area (target areas A and B) will be measured by comparing the total AK lesion counts pre-treatment (on Day 1 before study treatment has been applied) with the lesion counts measured.
Measured: day 1, day 21, day 42 and day 98.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startApr 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosario Rodríguez, Study director, Almirall, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358851
- Sponsor's protocol ID
- H 1005 6002 1007
- Status last verified
- May 2015
- First submitted
- 2 May 2011
- Last updated
- 29 May 2015
- Results posted
- No
Publications
Simon JC, Dominicus R, Karl L, Rodriguez R, Willers C, Dirschka T. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015 May;29(5):881-9. doi: 10.1111/jdv.12702. Epub 2014 Sep 25.
PubMed 25257941
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis
- ClinicalTrials.gov ID
- NCT01358851
- Acronym / sponsor ID
- H 1005 6002 1007
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 May 2011 (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 evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LAS41005Drug Las41005 |
| 2 | Other | Procedure: CryotherapyCryotherapy |
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 |
|---|---|---|
| Cryotherapy1-2 times during the treatment time | Procedure or surgery | 2 |
| LAS41005once daily | Drug | 1 |
Primary outcome
Histological status (AK diagnosis and grade) of one predefined target lesion
Time frame: Screening and 8 weeks after last treatment
Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade.
1 secondary outcome
Total Actinic keratoses (AK)lesion count at each visit
Time frame: day 1, day 21, day 42 and day 98.
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 29 May 2015.
- Derived from this study: PubMed 25257941Simon JC, Dominicus R, Karl L, Rodriguez R, Willers C, Dirschka T. A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. J Eur Acad Dermatol Venereol. 2015 May;29(5):881-9. doi: 10.1111/jdv.12702. Epub 2014 Sep 25.
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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.
Rosario Rodríguez study director
Almirall, S.A.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cryotherapy and LAS41005 in people with Actinic Keratosis, run by Almirall, S.A. at 4 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
Histological status (AK diagnosis and grade) of one predefined target lesion (time frame: Screening and 8 weeks after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358851, which also lists 1 linked publication.
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 29 May 2015.