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.

Study Overview

• Status: Completed
• Conditions: Atopic Eczema
• Intervention / Treatment: Drug: LAS 41002; Drug: Active

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Almirall Investigational Sites#1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active	Drug: Active; Active, once daily
Experimental: LAS 41002	Drug: LAS 41002; LAS 41002, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of skin reactions per patient as a measure of safety and tolerability	scoring will be performed by investigator	15 days
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	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 Adverse Events per patients as a measure of safety and tolerability	reporting will be performed by investigator	Daily

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Publications and helpful links

General 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.

Helpful Links

• Almirall Corporate Website

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Eczema; Skin Diseases; Dermatitis, Atopic
• Other Study ID Numbers: H 527 000-0917; 2009-017407-28 (EudraCT Number)