Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic Eczema

This study has been completed.
Sponsor:
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01119313
First received: April 29, 2010
Last updated: July 9, 2010
Last verified: July 2010

April 29, 2010
July 9, 2010
February 2010
March 2010   (final data collection date for primary outcome measure)
Change in total sum score of Clinical signs [ Time Frame: 15 days ] [ Designated as safety issue: No ]
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)
Same as current
Complete list of historical versions of study NCT01119313 on ClinicalTrials.gov Archive Site
  • change in skin hydration [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    measurement will be performed by corneometry, comparing data from baseline (day1) vs end of trial (day15)
  • Time dependancy of Skin penetration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    subject's 5 point assessment of perceived skin penetration will be performed for 2 hours after the first application
  • patient overall assessment [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    patient's intraindividual 5 point assessment on product on perception will be performed at end of trial (day15)
  • Number of skin reactions per patient as a measure of safety and tolerability [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    scoring will be performed by investigator
  • Number of Adverse Events per patients as a measure of safety and tolerability [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
    reporting will be performed by investigator
Same as current
Not Provided
Not Provided
 
Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic Eczema
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Eczema
  • Drug: LAS 41002
    LAS 41002, once daily
  • Drug: Active
    Active, once daily
  • Experimental: LAS 41002
    Intervention: Drug: LAS 41002
  • Active Comparator: Active
    Intervention: Drug: Active
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2010
March 2010   (final data collection date for primary outcome measure)

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

    1. erythema ≥ 2
    2. lichenification ≥ 1
    3. dryness ≥ 1
    4. itching ≥ 1
  • 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:

  • 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;
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01119313
H 527 000-0917, 2009-017407-28
No
godehard.ocker, Almirall Hermal GmbH
Almirall, S.A.
Not Provided
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
Almirall, S.A.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP