Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
1 other identifier
interventional
35
1 country
1
Brief Summary
Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease that has potential for profound and far-reaching effects on all aspects of children and their families lives, significantly reducing the quality of life. Atopic dermatitis typically appears in infancy and nowadays is affecting up to 10-30% of children and 2-10% of adults. Diminished skin barrier is the essential factor that plays a role in the initiation, consolidating and exacerbating AD. Treatment options for AD typically address skin barrier protection or inflammatory components of disease. Proper care using mild and appropriately formulated emollient preparations may provide significant benefits. In investigators prior study, more than half of pharmacy-derived emollient preparations contained potential contact haptens listed in the European baseline series (EBS), used in diagnosing contact dermatitis. The primary aim of this study is to demonstrate the efficacy of regularly applied emollient in an atomiser (in the form of oil-in-water emulsion) in maintenance therapy, in children presenting from mild to moderate atopic dermatitis. In this study 3 visits are planned (for a period of 4 weeks). During each visit investigators will evaluate transepidermal water loss (TEWL), capacitance of outer areas of the stratum corneum as an indirect assessment of skin hydration. Moreover, investigators will assess three-them-severityIndex and the Children's Dermatology Life Quality Index (CDLQI). The product that participants will use in the study, was prepared at investigators request, in collaboration with the cosmetics company, which according to investigators knowledge at present, will not be benefited from the audit. The following described study project (prospective clinical trial, uncontrolled, open-label) will be conducted within the framework of the statutory tasks of the Department of Pulmonology and Allergology of Children Medical University of Warsaw and is a non-commercial project.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedJune 14, 2016
June 1, 2016
5 months
April 25, 2016
June 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Transepidermal Water Loss (TEWL)
Standardized measurements of evaporation percutaneous (transepidermal water loss, TEWL) and capacitance outer areas of the stratum corneum giving indirect evaluation of skin hydration will be performed by the same researcher. The tests will be carried out always at the same point of the body.
4 weeks
Secondary Outcomes (2)
Change from the Children's Dermatology Life Quality Index (CDLQI )
4 weeks
Change from scoring atopic dermatitis index (SCORAD Index)
4 weeks
Other Outcomes (1)
Change from three-item-severity indicator (TIS)
4 weeks
Study Arms (1)
Emollient spray product
EXPERIMENTALStudy design A 3 visits are planned: 0 week (first visit) 2nd week (second visit) 4th week (third visit) B. During each visit will be made: 1. The clinical examination (including an assessment of any adverse effects) 2. Evaluation of transepidermal water loss (TEWL) and capacitance of outer areas of the stratum corneum as an indirect assessment of skin hydration, 3. fill out questionnaires CDLQI (The Children's Dermatology Life Quality Index) 4. will assess VAS (visual analogue scale) C. All patients will be instructed to use emollients spray the entire surface of the skin at least twice daily for four weeks.
Interventions
All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.
Eligibility Criteria
You may qualify if:
- A. Clinical diagnosis of atopic dermatitis (AD) using the criteria Hanifin and Rajka
You may not qualify if:
- A. severe atopic dermatitis (SCORAD Index over 40) B. oral steroids dose over 1 mg / kg. eq prednisolone or other oral immunosuppressive drugs during the last 3 days C. topical steroids or calcineurin inhibitors used more than 1 week D. viral skin infection (eg. Eczema herpeticum) or bacterial infections of the skin, E. severe systemic disease (kidney failure, heart disease, immunodeficiency)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Katarzyna Osinka
Warsaw, Żwirki I Wigury 63A, 00-090, Poland
Related Publications (2)
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PMID: 24813302BACKGROUNDZukiewicz-Sobczak WA, Adamczuk P, Wroblewska P, Zwolinski J, Chmielewska-Badora J, Krasowska E, Galinska EM, Cholewa G, Piatek J, Kozlik J. Allergy to selected cosmetic ingredients. Postepy Dermatol Alergol. 2013 Oct;30(5):307-10. doi: 10.5114/pdia.2013.38360. Epub 2013 Oct 30.
PMID: 24353491BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wojciech Feleszko, MD PhD
Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 5, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
June 14, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share