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Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis

NCT01597817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-12-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

chitosan coated textile

chitosan coated cotton long sleeved shirts and pants.

OTHER

chitosan free cotton long sleeved t-shirts and pants.

chitosan free cotton long sleeved shirts and pants.

Sponsors & Collaborators

  • Universidade Católica Portuguesa

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Luis Delgado, MD, PhD · Serviço e Laboratório de Imunologia, Faculdade de Medicina da Universidade do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597817 on ClinicalTrials.gov