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Completed

NCT Number: NCT01802580

Using an Internet Study to Improve Adherence for Psoriasis Patients

To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Internet Survey

Behavioral

fluocinonide 0.05% ointment

Drug

Other names: Fluonex, Lonide, Lyderm, Fluocinonide-E, Lidex, Lidex-E, Vanos, Licon, Dermacin, Fluex

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2013
Registry last updated
Jun 4, 2020

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.

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