Clinical vs. Anecdotal Evidence - Pediatric Atopic Dermatitis

Wake Forest University (WFU)

Status: Completed

Conditions: Atopic Dermatitis

Study type: Observational

Funder types: Other

Identifiers

NCT03559075

IRB00051332

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 480 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

480 participants in 8 patient groups

Group 1

Description:

Participants will be randomized into group 1 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 2

Description:

Participants will be randomized into group 2 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 3

Description:

Participants will be randomized into group 3 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 4

Description:

Participants will be randomized into group 4 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 5

Description:

Participants will be randomized into group 5 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 6

Description:

Participants will be randomized into group 6 to be queried about their comfort with a topical steroid for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 7

Description:

Participants will be randomized into group 7 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.

Group 8

Description:

Participants will be randomized into group 8 to be queried about their comfort with medication for treating their child's atopic dermatitis after hearing varying amounts of information about the treatment.