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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01802580
Other study ID # IRB00021783
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 2012
Est. completion date April 2016

Study information

Verified date May 2020
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Internet Survey

Drug:
fluocinonide 0.05% ointment


Locations

Country Name City State
United States Wake Forest University Health Sciences Department of Dermatology Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken 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 Mean of Days Per Week Medication Was Taken - Internet Survey The average number of days per week that participants reported taking the medication in the internet survey up to 12 months
Secondary Disease Severity With PASI 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
Secondary Disease Severity With IGA Assessment 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
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