Psoriasis
Conditions
Brief summary
To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.
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.
Interventions
BEHAVIORALInternet Survey
DRUGfluocinonide 0.05% ointment
Sponsors
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean of Days Per Week Medication Was Taken - Internet Survey | up to 12 months | The average number of days per week that participants reported taking the medication in the internet survey |
| Disease Severity With PASI | 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. |
| Disease Severity With IGA Assessment | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention - Internet Reminder Survey Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.
Internet Survey
fluocinonide 0.05% ointment | 11 |
| Standard of Care, no Internet Survey Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.
fluocinonide 0.05% ointment | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Other | 1 | 3 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Intervention - Internet Reminder Survey | Total | Standard of Care, no Internet Survey |
|---|---|---|---|
| Age, Continuous | 64.81 years | 62.05 years | 58.67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 20 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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
Time frame: up to 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention - Internet Reminder Survey | Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken | 15.14 Days |
| Standard of Care, no Internet Survey | Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken | 20.22 Days |
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).
Time frame: baseline and 12 months
Population: data not collected in all participants at month 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention - Internet Reminder Survey | Disease Severity With IGA Assessment | baseline | 2.6 score on a scale | Standard Deviation 0.6 |
| Intervention - Internet Reminder Survey | Disease Severity With IGA Assessment | month 12 | 2.5 score on a scale | Standard Deviation 0.52 |
| Standard of Care, no Internet Survey | Disease Severity With IGA Assessment | baseline | 2.5 score on a scale | Standard Deviation 0.61 |
| Standard of Care, no Internet Survey | Disease Severity With IGA Assessment | month 12 | 2.3 score on a scale | Standard Deviation 0.5 |
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.
Time frame: baseline and 12 months
Population: Data not collected on all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention - Internet Reminder Survey | Disease Severity With PASI | Baseline | 6.0 score on a scale | Standard Deviation 4.64 |
| Intervention - Internet Reminder Survey | Disease Severity With PASI | month 12 | 3.41 score on a scale | Standard Deviation 2.16 |
| Standard of Care, no Internet Survey | Disease Severity With PASI | Baseline | 4.31 score on a scale | Standard Deviation 2.96 |
| Standard of Care, no Internet Survey | Disease Severity With PASI | month 12 | 2.94 score on a scale | Standard Deviation 2.91 |
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
Time frame: up to 12 months
Population: Includes all participants randomized to this arm. Because the other arm has no internet reminder, there will only be one arm reported for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention - Internet Reminder Survey | Mean of Days Per Week Medication Was Taken - Internet Survey | 5.38 days per week |