Using an Internet Study to Improve Adherence for Psoriasis Patients

May 18, 2020 updated by: Wake Forest University
To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An investigator-blinded, prospective study of subjects with mild to moderate psoriasis will be conducted. Forty subjects ages 18 years and older will be enrolled.The Internet-based survey will be piloted to evaluate its effect on adherence to topical psoriasis medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their psoriasis on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care topical fluocinonide 0.05% ointment to be applied to affected areas on the skin twice daily. Adherence to fluocinonide will be assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects will be blinded to the adherence data until the final (Month 12) treatment visit.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any male or female 18 years or older of age with a diagnosis of mild to moderate psoriasis by a dermatologist will be eligible for participation.
  • Less than 20% of body surface involvement for psoriasis.
  • Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
  • The subject is able to complete the study and comply with study instructions, including attending all study visits.
  • In general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase health risk by study participation

Exclusion Criteria:

  • Individuals younger than 18 years of age.
  • Known allergy or sensitivity to topical fluocinonide.
  • Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
  • Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for psoriasis must be on a stable dose for at least 3 months prior to enrollment.
  • Any skin condition or disease that may require concurrent therapy or may confound evaluations
  • Current enrollment in any research study involving an investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention - internet reminder survey
Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.
Behavioral: Internet Survey
Drug: fluocinonide 0.05% ointment
Other Names:
  • Lidex
  • Vanos
  • Fluonex
  • Lonide
  • Lyderm
  • Fluocinonide-E
  • Lidex-E
  • Licon
  • Dermacin
  • Fluex
Experimental: Standard of care, no internet survey
Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.
Drug: fluocinonide 0.05% ointment
Other Names:
  • Lidex
  • Vanos
  • Fluonex
  • Lonide
  • Lyderm
  • Fluocinonide-E
  • Lidex-E
  • Licon
  • Dermacin
  • Fluex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken
Time Frame: up to 12 months

Number of days patients adhered to the treatment is reported. All subjects receive the MEMs caps on their medication and it is reported by the "number" of days that the "dosage" was taken correctly, either with or without internet reminder survey intervention.

number of days with a correct number of doses taken
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean of Days Per Week Medication Was Taken - Internet Survey
Time Frame: up to 12 months
The average number of days per week that participants reported taking the medication in the internet survey
up to 12 months
Disease Severity With PASI
Time Frame: baseline and 12 months
Psoriasis Area and Severity Index (PASI): The Psoriasis Area and Severity Index is commonly used in clinical trials as a granular measure of disease severity. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). It is weighted for area in each of the four body regions and scores erythema, induration and desquamation on an overall scale from 0-72. Treatment success is defined as a 75% reduction in PASI score from baseline value.
baseline and 12 months
Disease Severity With IGA Assessment
Time Frame: baseline and 12 months
Investigator's Global Assessment (IGA): Similar to assessment performed in clinical practice, based on a 6-point scale from 0 (completely clear) to 5 (very severe). Treatment success is defined as score of 0 or 1 (clear or almost clear).
baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University

Investigators

  • Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00021783

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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