PsoriasisNCT03168347
Assessing Patient Confidence in Biologic Medications
A study testing Anecdotal Evidence, Research Study Evidence and Anecdotal + Research Study Evidence in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Anecdotal Evidence, Research Study Evidence and Anecdotal + Research Study Evidence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 3 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with psoriasis (ICD-9: 696.1)
- Age 18-80
Who cannot join
- Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
- Currently or previously managed with a biologic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).
Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics 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. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.
- Conditions
- Psoriasis
- Being tested
- Anecdotal Evidence, Research Study Evidence, Anecdotal + Research Study Evidence, No Evidence
- Keywords
- Decision making
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anecdotal EvidenceBehavioural
Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.
Research Study EvidenceBehavioural
Communicate basic information on the therapeutic effect of a drug using only research study evidence.
Anecdotal + Research Study EvidenceBehavioural
Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.
No EvidenceBehavioural
Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.
| Study group | Role | What they receive |
|---|---|---|
| Anecdotal Evidence | Active comparator | Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence. Receives: Behavioral: Anecdotal Evidence |
| Research Study Evidence | Active comparator | Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence. Receives: Behavioral: Research Study Evidence |
| Anecdotal + Research Study Evidence | Active comparator | Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence. Receives: Behavioral: Anecdotal + Research Study Evidence |
| No Evidence | Placebo comparator | Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence. Receives: Behavioral: No Evidence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral survey responses
Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Jun 2017
- Primary completion3 Jun 2021
- Study completion3 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168347
- Sponsor's protocol ID
- IRB00043948
- Status last verified
- May 2025
- First submitted
- 24 May 2017
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Patient Confidence in Biologic Medications
- ClinicalTrials.gov ID
- NCT03168347
- Acronym / sponsor ID
- IRB00043948
- Conditions
- Psoriasis
- Keywords
- Decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 3 Jun 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).
Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics 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. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anecdotal Evidence | Active comparator | Behavioral: Anecdotal EvidenceScenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence. |
| Research Study Evidence | Active comparator | Behavioral: Research Study EvidenceScenario describes a medication's (biologic's) therapeutic effect results based on research study evidence. |
| Anecdotal + Research Study Evidence | Active comparator | Behavioral: Anecdotal + Research Study EvidenceScenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence. |
| No Evidence | Placebo comparator | Behavioral: No EvidenceScenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with psoriasis (ICD-9: 696.1)
- Age 18-80
Key exclusion criteria (2 listed)
- Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
- Currently or previously managed with a biologic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anecdotal EvidenceCommunicate basic information on the therapeutic effect of a drug using only anecdotal evidence. | Behavioural | Anecdotal Evidence |
| Research Study EvidenceCommunicate basic information on the therapeutic effect of a drug using only research study evidence. | Behavioural | Research Study Evidence |
| Anecdotal + Research Study EvidenceCommunicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence. | Behavioural | Anecdotal + Research Study Evidence |
| No EvidenceCommunicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence. | Behavioural | No Evidence |
Primary outcome
Oral survey responses
Time frame: 1 day
Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anecdotal Evidence, Research Study Evidence and Anecdotal + Research Study Evidence in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral survey responses (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.