Using an Internet Study to Improve Adherence for Psoriasis Patients

Condition(s) targeted: Psoriasis

Intervention: Internet Survey (Behavioral); fluocinonide 0.05% ointment (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Steven R Feldman, MD, PhD, Principal Investigator, Affiliation: Wake Forest School of Medicine

Overall contact:
Susie C Dowd, Phone: 336-716-3775, Email: sdowd@wakhealth.edu

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

Official title: Using an Internet Study to Improve Adherence for Psoriasis Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Measured MEMS Adherence

Secondary outcome:

MEMS cap relation to internet survey

Disease Severity with PASI and IGA assessment

MEMs cap data compared to PASI and IGA Assessment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Susie C Dowd, Phone: 336-716-3775, Email: sdowd@wakhealth.edu

Wake Forest School of Medicine - Dermatology Clinic, Winston Salem, North Carolina 27157, United States; Recruiting
Susie C Dowd, Phone: 336-716-3775, Email: sdowd@wakhealth.edu
Irma M Richardson, MHA, Phone: 336-716-2903, Email: irichard@wakehealth.edu
Steven R Feldman, MD, PhD, Principal Investigator

Starting date: October 2012
Last updated: December 10, 2014