Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis

In dermatology, topical anti-inflammatory medications, such as corticosteroids, are the mainstay treatment of managing patients with atopic dermatitis. However, caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. Many caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications. Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. The goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

Atopic dermatitis is the most common chronic, inflammatory dermatologic condition in young children, with a prevalence approaching 25% in some countries. Topical corticosteroids, the mainstay treatment in managing atopic dermatitis, generally function to decrease inflammation and suppress the immune response. Topical corticosteroids are grouped into distinct categories based on their degree of potency, including very high potency (Clobetasol propionate), high potency (triamcinolone acetonide), medium potency (fluocinonide), and low potency agents (desonide).

Caregivers are often apprehensive about choosing a topical steroid for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about treatment, or seeing the drug or its side effects negatively portrayed in the media. Many parents/caregivers are not aware that clinical trial evidence for these medications exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. By understanding what kind of information will allow caregivers to be confident in their decision to use a topical corticosteroid, dermatologists may improve treatment adherence and outcomes. The goal of the study is to learn whether caregivers are more confident in treating a child's atopic dermatitis after being presented with varying amounts of information about the treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parent/Caregiver of an individual age <1-17 years old
Subjects with a working knowledge of English

Exclusion criteria

Parent/Caregiver of an individual 18 years or older

Treatment and study plan

Primary outcomes

Survey responses on "willingness to treat"

Time frame: 1 day

Groups 1, 2, and 3 will be compared to assess whether caregivers are more willing to use a medication to manage their child's atopic dermatitis if presented with clinical trial evidence, anecdotal evidence, or both. Groups 4, 5, and 6 will be compared to assess whether caregivers are more willing to use a topical steroid to manage their child's atopic dermatitis if presented with clinical trial evidence, anecdotal evidence, or both. The results from groups 1, 2, and 3 will then be compared to the results from groups 4, 5, and 6 to assess whether the use of the word "steroid" impacts the caregiver's willingness to treat.
Survey responses on "willingness to treat with doctor's recommended medication"

Time frame: 1 day

Groups 7 and 8 will be compared to assess how caregiver's willingness to treat with a doctor's recommended medication is impacted by the exclusion of anecdotal evidence, clinical trial evidence, or both.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Assessing Caregiver's Confidence in the Use of Topical Corticosteroids for a Child's Atopic Dermatitis

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jun 15, 2018
Registry last updated: Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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