Using an Internet Study to Improve Adherence for Psoriasis Patients
Status: | Completed |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2017 |
Start Date: | October 2012 |
End Date: | April 2016 |
To evaluate whether participation in an Internet-based intervention helps improve short-term
and long-term psoriasis treatment outcomes, in particular, adherence.
and long-term psoriasis treatment outcomes, in particular, adherence.
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.
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.
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
We found this trial at
1
site
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
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