Atopic Dermatitis Clinical Trial
Official title:
Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
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.
| Status | Recruiting |
| Enrollment | 35 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 18 Years |
| Eligibility |
Inclusion Criteria: A. Clinical diagnosis of atopic dermatitis (AD) using the criteria Hanifin and Rajka Exclusion Criteria: 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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Poland | Katarzyna Osinka | Warszawa | Zwirki i Wigury 63A |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Warsaw |
Poland,
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. — View Citation
Zukiewicz-Sobczak WA, Adamczuk P, Wróblewska 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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change from three-item-severity indicator (TIS) | TIS evaluats the severity of erythema (max. 3 points), swelling (max. 3 points) and scratchs (max. 3 points), the maximum value of TIS = 9. | 4 weeks | No |
| Primary | 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 | No |
| Secondary | Change from the Children's Dermatology Life Quality Index (CDLQI ) | Courtesy of Professor A. Y. Finlay and Dr. M. S. Lewis-Jones of the Medical University of Cardiff during the study will be used a questionnaire about quality of life in children suffering from dermatological diseases. | 4 weeks | No |
| Secondary | Change from scoring atopic dermatitis index (SCORAD Index) | 4 weeks | No |
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