Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis (2ndDermisII)
|ClinicalTrials.gov Identifier: NCT01597817|
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : December 9, 2014
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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)
- 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
- 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)
- 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
- 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).
- 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.
- Genetic mutations [ Time Frame: 2 months ]Presence of the seven most common fillagrin gene mutations including R501X and c.2282del4
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597817
|Universidade do Porto|
|Study Director:||Luis Delgado, MD, PhD||Serviço e Laboratório de Imunologia, Faculdade de Medicina da Universidade do Porto|