Clinical trial NCT01119313: Study to Investigate Skin Conditions and Patient Assessment of LAS 41002 in the Treatment of Atopic Eczema
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Eczema
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in total sum score of Clinical signs
timeFrame: 15 days
Secondary outcomes:
measure: change in skin hydration
timeFrame: 15 days
measure: Time dependancy of Skin penetration
timeFrame: 2 hours
measure: patient overall assessment
timeFrame: 15 days
measure: Number of skin reactions per patient as a measure of safety and tolerability
timeFrame: 15 days
measure: Number of Adverse Events per patients as a measure of safety and tolerability
timeFrame: Daily
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#1
Study officials:
affiliation: Almirall Hermal GmbH
name: Christoph Willers, MD, MBA
role: STUDY_DIRECTOR
References:
citation: 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.