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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Atopic Eczema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LAS 41002

Group Type EXPERIMENTAL

LAS 41002

Intervention Type DRUG

LAS 41002, once daily

Active

Group Type ACTIVE_COMPARATOR

Active

Intervention Type DRUG

Active, once daily

Interventions

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LAS 41002

LAS 41002, once daily

Intervention Type DRUG

Active

Active, once daily

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No