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

NCT01119313 | Completed Phase 2

• 2 other identifiers: H 527 000-09172009-017407-28
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• change in skin hydration

  15 days

• Time dependancy of Skin penetration

  2 hours

• patient overall assessment

  15 days

• Number of skin reactions per patient as a measure of safety and tolerability

  15 days

• Number of Adverse Events per patients as a measure of safety and tolerability

  Daily

Study Arms (2)

LAS 41002

EXPERIMENTAL

Drug: LAS 41002

Active

ACTIVE COMPARATOR

Drug: Active

Interventions

LAS 41002 DRUG

LAS 41002, once daily

LAS 41002

Active DRUG

Active, once daily

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• erythema ≥ 2
• lichenification ≥ 1
• dryness ≥ 1
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Almirall Investigational Sites#1

Hamburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 22948032 DERIVED

Related Links

• Almirall Corporate Website

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christoph Willers, MD, MBA

  Almirall Hermal GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 7, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 12, 2010

Record last verified: 2010-07

Locations

DE (1)