Atopic EczemaPhase 2NCT01119313
Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic Eczema
A Phase 2 study testing LAS 41002 and Active in people with Atopic Eczema, run by Almirall, S.A. at 1 site in Germany.
Trial summary
The aim of the study is an intra-individual comparison of skin conditions in addition to a patient based assessment of product appearance in the topical treatment of atopic eczema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- LAS 41002 and Active
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 18 years or older;
- two comparable treatment areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of ≥ 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with
- erythema ≥ 2
- lichenification ≥ 1
- dryness ≥ 1
- itching ≥ 1
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- Erlangen atopy score sum equal or higher than 10 points (3);
- the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- written informed consent obtained
Who cannot join
- acne, suntan, eczema, hyperpigmentation or tattoos in the test areas;
- dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- evidence of drug or alcohol abuse;
- pregnancy or nursing;
- UV-therapy within 6 weeks before first treatment;
- symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
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- participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study;
- known allergic reactions to components of the study preparations, hypersensitivity against cetostearyl alcohol;
- treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before study day 1and throughout the study period (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
- contraindications according to summary of product characteristics;
- in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent;
- patient is institutionalized because of legal or regulatory order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single-center, Randomized, Controlled, Double-blind Study to Assess Effects on Skin Conditions and Patient Reported Outcome of a Topical Formulation Containing LAS41002 on Lesional Skin in Patients With Atopic Eczema
The aim of the study is an intra-individual comparison of skin conditions in addition to a patient based assessment of product appearance in the topical treatment of atopic eczema.
- Conditions
- Atopic Eczema
- Being tested
- LAS 41002, Active
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAS 41002Drug
LAS 41002, once daily
ActiveDrug
Active, once daily
| Study group | Role | What they receive |
|---|---|---|
| LAS 41002 | Experimental | Not described Receives: Drug: LAS 41002 |
| Active | Active comparator | Not described Receives: Drug: Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sum score of Clinical signs
scoring of clinical parameters (erythema, edema, crusting, excoriation, lichenification, dryness, itching) will be performed on a 4 point scale by investigator, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Secondary outcomes (5)
change in skin hydration
measurement will be performed by corneometry, comparing data from baseline (day1) vs end of trial (day15)
Measured: 15 days
Time dependancy of Skin penetration
subject's 5 point assessment of perceived skin penetration will be performed for 2 hours after the first application
Measured: 2 hours
patient overall assessment
patient's intraindividual 5 point assessment on product on perception will be performed at end of trial (day15)
Measured: 15 days
Number of skin reactions per patient as a measure of safety and tolerability
scoring will be performed by investigator
Measured: 15 days
Number of Adverse Events per patients as a measure of safety and tolerability
reporting will be performed by investigator
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
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 Atopic EczemaStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christoph Willers, MD, MBA, Study director, Almirall Hermal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119313
- Sponsor's protocol ID
- H 527 000-0917
- Other IDs
- 2009-017407-28, 2009
- Status last verified
- Jul 2010
- First submitted
- 29 Apr 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruzicka T, Willers C, Wigger-Alberti W. Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. Skin Pharmacol Physiol. 2012;25(6):305-12. doi: 10.1159/000341809. Epub 2012 Aug 31.
PubMed 22948032
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-center, Randomized, Controlled, Double-blind Study to Assess Effects on Skin Conditions and Patient Reported Outcome of a Topical Formulation Containing LAS41002 on Lesional Skin in Patients With Atopic Eczema
- ClinicalTrials.gov ID
- NCT01119313
- Acronym / sponsor ID
- H 527 000-0917
- Conditions
- Atopic Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 7 May 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 the study is an intra-individual comparison of skin conditions in addition to a patient based assessment of product appearance in the topical treatment of atopic eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAS 41002 | Experimental | Drug: LAS 41002 |
| Active | Active comparator | Drug: Active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- men and women aged 18 years or older;
- two comparable treatment areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of ≥ 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with
- Erlangen atopy score sum equal or higher than 10 points (3);
- the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- female patients of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
Key exclusion criteria (12 listed)
- acne, suntan, eczema, hyperpigmentation or tattoos in the test areas;
- dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- evidence of drug or alcohol abuse;
- pregnancy or nursing;
- UV-therapy within 6 weeks before first treatment;
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 |
|---|---|---|
| LAS 41002LAS 41002, once daily | Drug | LAS 41002 |
| ActiveActive, once daily | Drug | Active |
Primary outcome
Change in total sum score of Clinical signs
Time frame: 15 days
scoring of clinical parameters (erythema, edema, crusting, excoriation, lichenification, dryness, itching) will be performed on a 4 point scale by investigator, comparing data from baseline (day1) vs end of trial (day15)
5 secondary outcomes
change in skin hydration
Time frame: 15 days
Time dependancy of Skin penetration
Time frame: 2 hours
patient overall assessment
Time frame: 15 days
Number of skin reactions per patient as a measure of safety and tolerability
Time frame: 15 days
Number of Adverse Events per patients as a measure of safety and tolerability
Time frame: Daily
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 12 Jul 2010.
- Derived from this study: PubMed 22948032Ruzicka T, Willers C, Wigger-Alberti W. Efficacy and patient-reported outcomes of a new mometasone cream treating atopic eczema. Skin Pharmacol Physiol. 2012;25(6):305-12. doi: 10.1159/000341809. Epub 2012 Aug 31.
- Almirall Corporate 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.
Christoph Willers, MD, MBA study director
Almirall Hermal GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LAS 41002 and Active in people with Atopic Eczema, 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 10 inclusion and 12 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 12 Jul 2010. 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. 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?
Change in total sum score of Clinical signs (time frame: 15 days). 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 NCT01119313, 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 12 Jul 2010.