Clinical trial NCT02763722: Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
Official title: Evaluating Results of Regularly Applied Emollient - Spray in Atopic Dermatitis Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
allergic contact dermatitis
cosmetics
transepidermal water loos
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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. The skin exposed to aeroallergens (pollen, pet dander, dust mites), or food allergens (eggs, milk, wheat protein, chocolate, strawberry), hard water, and soaps and detergents, loses the protective barrier composed of lipids (ie. Lipid) and becomes the victim of harmful, exogenous substances.

The main symptoms of atopic dermatitis are redness and dry skin, itching, moreover patients are susceptible to recurrent superficial skin infections. Skin lesions in AD are mostly located on the elbows and knees, face and neck, however they can spans the entire body. 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.

Previous observations indicated to be reasonable to selection carefully composition of emollient preparations. In investigators prior study, more than half of emollient preparations, available in online drugstores, contained potential contact sensitizers, included to 28, the most common, haptens listed in the European baseline series (EBS), used in diagnosing contact dermatitis. A significant number of investigated products contained at least two different haptens which may threaten unpredictable allergic reactions in the case of concomitance of various allergens.

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.

The composition of the tested emollient is typical and based on the frequently occurring substances found in public preparations of this kind.

Emollient spray (composition INCI):

Aqua, Glycerin, Aqua, Parfum, Glyceryl Caprylate, Allantoin, Xanthan Gum, Butyrospermum Parkii Butter, Adansonia digitata Seed Oil, Oenothera Biennis Oil, Perilla ocymoides Seed Oil, Tocopheryl Acetate, Palm Kernel Glycerides, Squalane, behenyl Alcohol, Glyceryl Stearate, Palmitic Acid, Stearic Acid, Lecythin, Cetyl Alcohol, Myristyl Alcohol, Ceramide NP, Glyceryl Stearate Citrate, Cetearyl Alcohol, Tocopheryl Acetate, Caprylic / Capric Trigliceride, Dicaprylyl Carbonate, Tocopherol, Etylhexyl Stearate.

The product that will be used in the study (emollients in spray- composition of the product given above) 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from Transepidermal Water Loss (TEWL)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from the Children's Dermatology Life Quality Index (CDLQI )
timeFrame: 4 weeks
measure: Change from scoring atopic dermatitis index (SCORAD Index)
timeFrame: 4 weeks
Other outcomes:
measure: Change from three-item-severity indicator (TIS)
timeFrame: 4 weeks
Locations:
city: Warszawa
country: Poland
facility: Katarzyna Osinka
state: Żwirki i Wigury 63A
Study officials:
affiliation: Department of Pediatric Respiratory Diseases and Allergy, The Medical University of Warsaw
name: Wojciech Feleszko, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zukiewicz-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.