Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01597817
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2012-05-10
Brief Title:
Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis
Sponsor:
Universidade do Porto
Organization:
Universidade do Porto
Study Overview
Official Title:
A Randomized Controlled Trial of the Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2ndDermisII
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
Detailed Description:
This randomized controlled trial will examine the efficacy and safety of a bio functional textile in the treatment of atopic dermatitis AD
Atopic dermatitis subjects will be randomized to placebo or active group and asked to wear cotton long sleeved shirts and pants single cotton versus cotton coated with chitosanas pyjamas during the night for a 2 month period
Atopic dermatitis is defined by Haniffin and Rafka criteria Rothe MJ et al 2006 - must have three or more of major criteria
1 Pruritus
2 Typical morphology and distribution
1 Flexural lichenification or linearity in adults
2 Facial and extensor involvement in infants and children
3 Chronic or chronically-relapsing dermatitis
4 Personal or family history of atopy asthma allergic rhinitis atopic dermatitis
OR should have three or more of minor criteria
XerosisIchthyosis palmar hyperlinearity or keratosis pilaris Immediate type I skin-test reactivity raised serum IgE early age of onset tendency toward cutaneous infections especially S aureus and herpes simplex or impaired cell-mediated immunity tendency toward non-specific hand or foot dermatitis nipple eczema cheilitis recurrent conjunctivitis dennie-Morgan infraorbital fold keratoconus anterior subcapsular cataractsorbital darkening facial pallor or facial erythema pityriasis alba anterior neck folds itch when sweatingintolerance to wool and lipid solventsperifollicular accentuationfood intolerancecourse influenced by environmental or emotional factorswhite dermographism
PROCEDURES After screening subjects will enter a run in period of 2 weeks Patients meeting Hannifin and Radjka criteria for AD will be randomized to chitosan free or chitosan coated cotton long sleeved t-shirts and pants
Intervention will continue for 2 months The medical investigator will be blind to intervention when comparing AD severity at the beginning and end of the study
Study Schedule
Visit 0
Explain study protocol
Review medical history to determine eligibility based on inclusionexclusion criteria
Schedule visit 1
Visit 1
Provide written information about the study
Obtain signature of potential subject on written informed consent
Perform medical examination and register SCORAD index
Answer Dermatology quality of life questionnaire
Patients are explained and given a diary symptoms card
Perform skin swab of determined areas 25 cm2 of occipital interscapular brachial and popliteal areas
Perform serum sampling
Patients are explained trial and are given a Shirt and pants
Surveillance and medical care if required
Visit 2
Review medical history including medications history
Perform medical examination and register SCORAD index
Answer a quality of life questionnaire
Deliver the diary symptoms card
Perform skin swab of determined areas
Perform serum sampling Visits will be performed at an appropriate medical setting Each visit will last approximately 45 min
Primary Outcomes
1 Investigator rated eczema severity clinical improvement measured by 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 To determine extent the sites affected by eczema are shaded on a drawing of a body The rule of 9 is used to calculate the affected area A as a percentage of the whole body Head and neck 9 Upper limbs 9 each Lower limbs 18 each Anterior trunk 18 Back 18 1 each for genitals each palm and the back of each hand The score for each area is added up
The total area is A which has a possible maximum of 100 A representative area of eczema is selected In this area the intensity of each of the following signs is assessed as none 0 mild 1 moderate 2 or severe 3Redness Swelling Oozing crusting Scratch marks Skin thickening lichenificationDryness this is assessed in an area where there is no inflammation The intensity scores are added together to give B maximum 18 Subjective symptoms ie itch and sleeplessness are each scored by the patient or relative using a visual analogue scale where 0 is no itch or no sleeplessness and 10 is the worst imaginable itch or sleeplessness These scores are added to give C maximum 20
2 Changes in Quality of life Patients are asked to answer the Portuguese version of the Dermatology Life Quality Index 16 years old or the childrens Dermatology Quality of Life Index 4-16 years old at the beginning and end of the study
Secondary Outcomes
1 Changes in 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
2 Changes in the need of eczema treatment patients are asked to record the use of topical steroids antihistamines oral steroids or immunosuppressive drugs on a diary card
3 Immunological serum markers changes in serum total IgE specific IgE to enterotoxin AB C and TSST staphylococcus enterotoxins serum eosinophil cationic protein ECP blood eosinophils C reactive protein Changes in cytokine serum levels RANTES IL-31 IL-18IL-16
4 Changes in skin microflora 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 from the beginning to the end of study
5 Presence of the seven most common filaggrin gene mutations including R501X and c2282del4
INVESTIGATIONAL PRODUCT Acquisition Textiles will be provided by textile enterprise Crispim e Abreu Lda
Formulation and packaging will be done as usual in textiles Chitosan coated or chitosan free garments will be indistinguishable
Atopic dermatitis subjects will be randomized to placebo or active group and asked to wear cotton long sleeved shirts and pants single cotton versus cotton coated with chitosanas pyjamas during the night for a 2 month period
Atopic dermatitis is defined by Haniffin and Rafka criteria Rothe MJ et al 2006 - must have three or more of major criteria
1 Pruritus
2 Typical morphology and distribution
1 Flexural lichenification or linearity in adults
2 Facial and extensor involvement in infants and children
3 Chronic or chronically-relapsing dermatitis
4 Personal or family history of atopy asthma allergic rhinitis atopic dermatitis
OR should have three or more of minor criteria
XerosisIchthyosis palmar hyperlinearity or keratosis pilaris Immediate type I skin-test reactivity raised serum IgE early age of onset tendency toward cutaneous infections especially S aureus and herpes simplex or impaired cell-mediated immunity tendency toward non-specific hand or foot dermatitis nipple eczema cheilitis recurrent conjunctivitis dennie-Morgan infraorbital fold keratoconus anterior subcapsular cataractsorbital darkening facial pallor or facial erythema pityriasis alba anterior neck folds itch when sweatingintolerance to wool and lipid solventsperifollicular accentuationfood intolerancecourse influenced by environmental or emotional factorswhite dermographism
PROCEDURES After screening subjects will enter a run in period of 2 weeks Patients meeting Hannifin and Radjka criteria for AD will be randomized to chitosan free or chitosan coated cotton long sleeved t-shirts and pants
Intervention will continue for 2 months The medical investigator will be blind to intervention when comparing AD severity at the beginning and end of the study
Study Schedule
Visit 0
Explain study protocol
Review medical history to determine eligibility based on inclusionexclusion criteria
Schedule visit 1
Visit 1
Provide written information about the study
Obtain signature of potential subject on written informed consent
Perform medical examination and register SCORAD index
Answer Dermatology quality of life questionnaire
Patients are explained and given a diary symptoms card
Perform skin swab of determined areas 25 cm2 of occipital interscapular brachial and popliteal areas
Perform serum sampling
Patients are explained trial and are given a Shirt and pants
Surveillance and medical care if required
Visit 2
Review medical history including medications history
Perform medical examination and register SCORAD index
Answer a quality of life questionnaire
Deliver the diary symptoms card
Perform skin swab of determined areas
Perform serum sampling Visits will be performed at an appropriate medical setting Each visit will last approximately 45 min
Primary Outcomes
1 Investigator rated eczema severity clinical improvement measured by 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 To determine extent the sites affected by eczema are shaded on a drawing of a body The rule of 9 is used to calculate the affected area A as a percentage of the whole body Head and neck 9 Upper limbs 9 each Lower limbs 18 each Anterior trunk 18 Back 18 1 each for genitals each palm and the back of each hand The score for each area is added up
The total area is A which has a possible maximum of 100 A representative area of eczema is selected In this area the intensity of each of the following signs is assessed as none 0 mild 1 moderate 2 or severe 3Redness Swelling Oozing crusting Scratch marks Skin thickening lichenificationDryness this is assessed in an area where there is no inflammation The intensity scores are added together to give B maximum 18 Subjective symptoms ie itch and sleeplessness are each scored by the patient or relative using a visual analogue scale where 0 is no itch or no sleeplessness and 10 is the worst imaginable itch or sleeplessness These scores are added to give C maximum 20
2 Changes in Quality of life Patients are asked to answer the Portuguese version of the Dermatology Life Quality Index 16 years old or the childrens Dermatology Quality of Life Index 4-16 years old at the beginning and end of the study
Secondary Outcomes
1 Changes in 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
2 Changes in the need of eczema treatment patients are asked to record the use of topical steroids antihistamines oral steroids or immunosuppressive drugs on a diary card
3 Immunological serum markers changes in serum total IgE specific IgE to enterotoxin AB C and TSST staphylococcus enterotoxins serum eosinophil cationic protein ECP blood eosinophils C reactive protein Changes in cytokine serum levels RANTES IL-31 IL-18IL-16
4 Changes in skin microflora 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 from the beginning to the end of study
5 Presence of the seven most common filaggrin gene mutations including R501X and c2282del4
INVESTIGATIONAL PRODUCT Acquisition Textiles will be provided by textile enterprise Crispim e Abreu Lda
Formulation and packaging will be done as usual in textiles Chitosan coated or chitosan free garments will be indistinguishable
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None