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

NCT01597817 | Completed Phase 2

• 1 other identifier: UP-AD-2012
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Eczema; Textiles

Outcome Measures

Primary Outcomes (2)

• Score of severity of Atopic Dermatitis (SCORAD)

  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 months

• Quality of life

  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

  2 months

Secondary Outcomes (5)

• Participant rated symptoms of eczema

  2 months

• Need of eczema treatment

  2 months

• Immunological serum markers

  2 months

• Skin microflora

  2 months

• Genetic mutations

  2 months

Study Arms (2)

chitosan coated textile

ACTIVE COMPARATOR

Chitosan coated cotton long sleeved t-shirts and pants.

Other: chitosan coated textile

chitosan free cotton textile

PLACEBO COMPARATOR

Chitosan free cotton long sleeved t-shirts and pants.

Other: chitosan free cotton long sleeved t-shirts and pants.

Interventions

chitosan coated textile OTHER

chitosan coated cotton long sleeved shirts and pants.

chitosan coated textile

chitosan free cotton long sleeved t-shirts and pants. OTHER

chitosan free cotton long sleeved shirts and pants.

chitosan free cotton textile

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Universidade Católica Portuguesa: collaborator

Study Sites (1)

Universidade do Porto

Porto, Portugal

Location

Related Publications (7)

• Eigenmann PA. Clinical features and diagnostic criteria of atopic dermatitis in relation to age. Pediatr Allergy Immunol. 2001;12 Suppl 14:69-74. doi: 10.1034/j.1399-3038.2001.121416.x. No abstract available.

  PMID: 11380904 BACKGROUND

• Fernandes JC, Tavaria FK, Fonseca SC, Ramos OS, Pintado ME, Malcata FX. In vitro screening for anti-microbial activity of chitosans and chitooligosaccharides, aiming at potential uses in functional textiles. J Microbiol Biotechnol. 2010 Feb;20(2):311-8. doi: 10.4014/jmb.0904.04038.

  PMID: 20208434 BACKGROUND

• Gupta AK, Batra R, Bluhm R, Boekhout T, Dawson TL Jr. Skin diseases associated with Malassezia species. J Am Acad Dermatol. 2004 Nov;51(5):785-98. doi: 10.1016/j.jaad.2003.12.034.

  PMID: 15523360 BACKGROUND

• Boguniewicz M, Leung DY. Recent insights into atopic dermatitis and implications for management of infectious complications. J Allergy Clin Immunol. 2010 Jan;125(1):4-13; quiz 14-5. doi: 10.1016/j.jaci.2009.11.027.

  PMID: 20109729 BACKGROUND

• Wu, Y.-B., Yu, S.-H., Mi, F.-L., Wu, C.-W., Shyu, S.-S., Peng, C.-K. and Chao, A.-C. 2004. Preparation and characterization on mechanical and antibacterial properties of chitosan/cellulose blends. Carbohydrate Polymers 57: 435-440

  BACKGROUND

• Lopes C, Duarte AF, Correia O, Delgado L. [Atopic dermatitis, innate immunity, and infection]. Dermatol Online J. 2011 Aug 15;17(8):4. Portuguese.

  PMID: 21906484 BACKGROUND

• Lopes C, Soares J, Tavaria F, Duarte A, Correia O, Sokhatska O, Severo M, Silva D, Pintado M, Delgado L, Moreira A. Chitosan Coated Textiles May Improve Atopic Dermatitis Severity by Modulating Skin Staphylococcal Profile: A Randomized Controlled Trial. PLoS One. 2015 Nov 30;10(11):e0142844. doi: 10.1371/journal.pone.0142844. eCollection 2015.

  PMID: 26618557 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Luis Delgado, MD, PhD

  Serviço e Laboratório de Imunologia, Faculdade de Medicina da Universidade do Porto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cristina Lopes

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

PT (1)