Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis (2ndDermisII)
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|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|
|Primary Completion Date :||June 2012|
|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
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 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|