Oral Psoriasis Treatment Adherence and Intervention Study
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ClinicalTrials.gov Identifier: NCT02850900 |
Recruitment Status :
Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : October 27, 2020
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Response to psoriasis treatment is variable in large part because of poor adherence treatments. Studies using electronic monitors have assessed adherence to topical and injectable psoriasis treatments and to biologics, yielding critically important insights. Adherence to oral psoriasis treatments is not as well characterized but is also critical, as the therapeutic windows for these treatments are narrower than for other psoriasis treatment options.
The proposed study will assess patients' adherence to oral psoriasis treatment (primarily methotrexate) and will also collect pilot data on an intervention to improve adherence. The primary hypothesis of the investigators study is that adherence to oral psoriasis treatment is poor and that a reporting intervention may improve adherence to oral psoriasis treatment. In the investigator-blinded, 6-month prospective study, patients will be randomized to standard-of-care treatment or standard-of-care supplemented with the weekly online reporting intervention. Adherence will be assessed using electronic monitors. This randomized trial will permit the investigators to determine adherence to oral psoriasis treatment, assess the relationship between adherence and psoriasis outcomes, identify factors that are associated with adherence to oral psoriasis treatment (including physician trust, confidence in the treatment plan, and depression), and obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment
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Condition or disease | Intervention/treatment | Phase |
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Psoriasis | Behavioral: Internet Survey | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Oral Psoriasis Treatment Adherence and Intervention Study |
Study Start Date : | April 2016 |
Actual Primary Completion Date : | July 2018 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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Experimental: Internet Survey
Subject will receive an electronic survey weekly to complete
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Behavioral: Internet Survey
Weekly survey will be emailed, subjects should complete them |
No Intervention: No Survey
No intervention
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- Adherence to prescribed oral Methotrexate treatment [ Time Frame: 6 months ]Determined by intervention of weekly internet survey compared to no survey
- Patterns of Misuse [ Time Frame: 6 months ]Self-report of not taking the medication as prescribed;
- Psoriasis severity outcomes [ Time Frame: 6 months ]The relationship between body surface area, Physician Global Assessment outcomes will be assessed.
- Relationship to Adherence [ Time Frame: 6 months ]It will be explored using physician trust scale, a validated tool.
- Relationship to Satisfaction [ Time Frame: 6 months ]It will be explored using the treatment and satisfaction survey, a validated survey.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Any male or female 12 years or older of age with a diagnosis of psoriasis who is prescribed methotrexate by a dermatologist will be eligible for participation.
- Greater than 10% 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.
Exclusion Criteria:
- Individuals younger than 12 years of age.
- Known allergy or sensitivity to methotrexate.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850900
United States, North Carolina | |
Wake Forest University School of Medicine - Department of Dermatology | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | William H Huang, MD | Wake Forest |
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT02850900 |
Other Study ID Numbers: |
IRB00035938 |
First Posted: | August 1, 2016 Key Record Dates |
Last Update Posted: | October 27, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | will determine at later date |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |