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

This study has been completed.
Sponsor:
Information provided by:
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01119313
First received: April 29, 2010
Last updated: July 9, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Atopic Eczema
Drug: LAS 41002
Drug: Active
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Change in total sum score of Clinical signs [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • change in skin hydration [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    measurement will be performed by corneometry, comparing data from baseline (day1) vs end of trial (day15)

  • Time dependancy of Skin penetration [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    subject's 5 point assessment of perceived skin penetration will be performed for 2 hours after the first application

  • patient overall assessment [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    patient's intraindividual 5 point assessment on product on perception will be performed at end of trial (day15)

  • Number of skin reactions per patient as a measure of safety and tolerability [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    scoring will be performed by investigator

  • Number of Adverse Events per patients as a measure of safety and tolerability [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
    reporting will be performed by investigator


Enrollment: 20
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS 41002 Drug: LAS 41002
LAS 41002, once daily
Active Comparator: Active Drug: Active
Active, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119313

Locations
Germany
Almirall Investigational Sites#1
Hamburg, Germany
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
  More Information

Additional Information:
No publications provided by Almirall, S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: godehard.ocker, Almirall Hermal GmbH
ClinicalTrials.gov Identifier: NCT01119313     History of Changes
Other Study ID Numbers: H 527 000-0917, 2009-017407-28
Study First Received: April 29, 2010
Last Updated: July 9, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Eczema
Dermatitis, Atopic
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014