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Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis (2ndDermisII)

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. Identifier: NCT01597817
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : December 9, 2014
Universidade Católica Portuguesa
Information provided by (Responsible Party):
Cristina Lopes, Universidade do Porto

Brief Summary:
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by exacerbations and remission of intensely pruritic lesions of variable location. AD may be acute (short-term and severe) with predominantly redness, vesicles and oozing, or it may be chronic (long-term) with scaling, skin thickening, altered pigmentation and exaggerated surface markings. The condition affects mainly the creases of the elbows and knees, and the face and neck, although it can affect any part of the body. The severity of AD is variable, ranging from localized mild scaling to generalized involvement of the whole body. Itching is the predominant symptom, which can induce a vicious cycle of scratching, leading to skin damage. There is a tendency to lifelong dry sensitive skin. Skin of AD is often colonized by Staphylococcus aureus contributing to perpetuating cutaneous inflammation. AD treatment is based on skin hydration, identification and elimination of flare factors, and pharmacologic therapy. Biofunctional textiles are emerging as new and complementary tools . Chitosan is a natural polysaccharide with in vitro anti-microbial activity and regenerating properties. The investigators aim to evaluate the effect of a textile coated with chitosan in AD treatment as well as its impact on systemic inflammation and skin microbiome. The investigators hypothesize the use of biofunctional textile coated with chitosan will improve severity of AD , quality of life and diminish skin colonization with Staphylococcus aureus and some skin moulds, namely Malassezia.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Other: chitosan coated textile Other: chitosan free cotton long sleeved t-shirts and pants. Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: chitosan coated textile
Chitosan coated cotton long sleeved t-shirts and pants.
Other: chitosan coated textile
chitosan coated cotton long sleeved shirts and pants.

Placebo Comparator: chitosan free cotton textile
Chitosan free cotton long sleeved t-shirts and pants.
Other: chitosan free cotton long sleeved t-shirts and pants.
chitosan free cotton long sleeved shirts and pants.

Primary Outcome Measures :
  1. Score of severity of Atopic Dermatitis (SCORAD) [ Time Frame: 2 months ]
    Investigator rated eczema severity: clinical improvement measured by local SCORAD (score of severity of AD)(initial versus final, % of change). SCORAD is composed of three different domains (A= extension B= intensity C = subjective symptoms)

  2. Quality of life [ Time Frame: 2 months ]
    Changes in Quality of life. Patients are asked to answer the Portuguese version of the Dermatology Life Quality Index (> 16 years old) or the children´s Dermatology Quality of Life Index (4-16 years old) at the beginning and end of the study

Secondary Outcome Measures :
  1. Participant rated symptoms of eczema [ Time Frame: 2 months ]
    Participant rated symptoms of eczema: patients are asked to record the severity scores of itchiness and sleep disturbance of the previous day in a diary card (10 point scale from 0-none to 10-extreme)

  2. Need of eczema treatment [ Time Frame: 2 months ]
    Patients are asked to record the use of topical steroids, antihistamines, oral steroids or immunosuppressive drugs on a diary card

  3. Immunological serum markers [ Time Frame: 2 months ]
    Changes in serum total IgE, specific IgE to enterotoxin A,B, C and TSST (staphylococcus enterotoxins) serum eosinophil cationic protein (ECP), blood eosinophils, C reactive protein. Changes in cytokine serum levels (RANTES, Interleukin-31, IL-18, IL-16).

  4. Skin microflora [ Time Frame: 2 months ]
    characterize the skin microflora of 25 cm2 of popliteal, brachial intertriginous areas , interscapular and occipital region and determine the changes in number of colony forming units of Staphylococcus aureus and moulds at the beginning and end of study.

  5. Genetic mutations [ Time Frame: 2 months ]
    Presence of the seven most common fillagrin gene mutations including R501X and c.2282del4

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of Atopic Dermatitis
  • older than 12 years old

Exclusion Criteria:

  • other specific forms of eczema such as contact eczema, seborrheic eczema, nummular eczema, occupational dermatitis, hand eczema
  • systemic diseases that can be accompanied by immunological skin abnormalities as psoriasis;
  • clinically significant chronic infectious disease(s) (eg, HIV, hepatitis B or C);
  • breastfeeding,pregnant/intending to become pregnant during study;
  • participation in any other clinical study;
  • part of the staff personnel involved with the study;
  • family member of investigational/study staff.

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 identifier (NCT number): NCT01597817

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Universidade do Porto
Porto, Portugal
Sponsors and Collaborators
Universidade do Porto
Universidade Católica Portuguesa
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Study Director: Luis Delgado, MD, PhD Serviço e Laboratório de Imunologia, Faculdade de Medicina da Universidade do Porto

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cristina Lopes, Universidade do Porto Identifier: NCT01597817     History of Changes
Other Study ID Numbers: UP-AD-2012
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Cristina Lopes, Universidade do Porto:
Atopic dermatitis

Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Chelating Agents
Sequestering Agents