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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Faculdade de Medicina da Universidade do Porto, Portugal
Escola Superior de Biotecnologia, Porto, Universidade Católica Portuguesa
Information provided by (Responsible Party):
Cristina Lopes, Universidade do Porto
ClinicalTrials.gov Identifier:
NCT01597817
First received: May 10, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by Universidade do Porto:

Primary Outcome Measures:
  • Score of severity of Atopic Dermatitis (SCORAD) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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)

  • Quality of life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • Participant rated symptoms of eczema [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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)

  • Need of eczema treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Patients are asked to record the use of topical steroids, antihistamines, oral steroids or immunosuppressive drugs on a diary card

  • Immunological serum markers [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).

  • Skin microflora [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.

  • Genetic mutations [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Presence of the seven most common fillagrin gene mutations including R501X and c.2282del4


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597817

Locations
Portugal
Universidade do Porto
Porto, Portugal
Sponsors and Collaborators
Universidade do Porto
Faculdade de Medicina da Universidade do Porto, Portugal
Escola Superior de Biotecnologia, Porto, Universidade Católica Portuguesa
Investigators
Study Director: Luis Delgado, MD, PhD Serviço e Laboratório de Imunologia, Faculdade de Medicina da Universidade do Porto
  More Information

Publications:

Responsible Party: Cristina Lopes, Universidade do Porto
ClinicalTrials.gov Identifier: NCT01597817     History of Changes
Other Study ID Numbers: UP-AD-2012
Study First Received: May 10, 2012
Last Updated: December 19, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Universidade do Porto:
Atopic dermatitis
Eczema
Textiles

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chitosan
Chelating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 21, 2013