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

Atopic Eczema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119313
• Other study ID #: H 527 000-0917
• Secondary ID: 2009-017407-28
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2010
• Last updated: July 9, 2010
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Diseases

Intervention

Drug:
• LAS 41002
LAS 41002, once daily
• Active
Active, once daily

Locations

Country	Name	City	State
Germany	Almirall Investigational Sites#1	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	change in skin hydration	measurement will be performed by corneometry, comparing data from baseline (day1) vs end of trial (day15)	15 days	No
Secondary	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	No
Secondary	patient overall assessment	patient's intraindividual 5 point assessment on product on perception will be performed at end of trial (day15)	15 days	No
Secondary	Number of skin reactions per patient as a measure of safety and tolerability	scoring will be performed by investigator	15 days	Yes
Secondary	Number of Adverse Events per patients as a measure of safety and tolerability	reporting will be performed by investigator	Daily	Yes

External Links

•   Almirall Corporate Website