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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017407-28 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS 41002 | Experimental |
| |
| Active | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS 41002 | Drug | LAS 41002, once daily |
| |
| Active |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| change in skin hydration | measurement will be performed by corneometry, comparing data from baseline (day1) vs end of trial (day15) | 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 |
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Inclusion Criteria:
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;
written informed consent obtained
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Willers, MD, MBA | Almirall Hermal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Sites#1 | Hamburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22948032 | Derived | 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. |
| Label | URL |
|---|---|
| Almirall Corporate Website | View source |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Drug |
Active, once daily |
|
| 2 hours |
| patient overall assessment | patient's intraindividual 5 point assessment on product on perception will be performed at end of trial (day15) | 15 days |
| Number of skin reactions per patient as a measure of safety and tolerability | scoring will be performed by investigator | 15 days |
| Number of Adverse Events per patients as a measure of safety and tolerability | reporting will be performed by investigator | Daily |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |