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Assessment of the Effects on Barrier Impairment, Clinical Features and Bacterial Colonization of Topical Formulations in Patients With Atopic Eczema; a Phase IIa, Single-center, Randomized, Observer-blind Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863005
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : November 6, 2009
Sponsor:
Information provided by:
Moberg Pharma AB

Brief Summary:
The purpose of the study is the assessment of the barrier impairment, clinical skin condition and bacterial colonization status in patients with atopic eczema following topical treatment with K201 cream and a comparator twice daily over a 4-week treatment period.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: K201 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1. K201 Drug: K201
Cream

Drug: K201
Active Comparator: 2. Drug: K201
Cream

Drug: K201



Primary Outcome Measures :
  1. Transepidermal water loss (TEWL), clinical assessments, corneometry, bacterial counts [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • signed written informed consent obtained;
  • male or female patients, 18 years or older;
  • manifest atopic eczema diagnosed according to Hanifin and Rajka;
  • two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate (meeting Hanifin and Rajka´s criteria;
  • TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas;
  • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
  • sexually active females of childbearing potential should either be surgically sterile hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen:systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide.

Exclusion Criteria:

  • acne, eczema other than atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
  • suntan which in the opinion of the investigator prevents correct assessments
  • 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;
  • participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
  • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
  • known allergic reactions to components of the study preparation and the comparator;
  • treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before the beginning of the study (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);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863005


Locations
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Germany
bioskin GmbH
Hamburg, Germany
Sponsors and Collaborators
Moberg Pharma AB
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ClinicalTrials.gov Identifier: NCT00863005    
Other Study ID Numbers: K201-I/280301BS
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: November 6, 2009
Last Verified: November 2009
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases