Plaque Psoriasis, Psoriasis Vulgaris
Conditions
Keywords
Psoriasis, Plaque psoriasis, with bilateral symmetrical lesions., A diagnosis of stable plaque-type psoriasis vulgaris, with at least one pair of symmetric lesions on either, the trunk, arms, or legs that would serve as target lesions.
Brief summary
The purpose of this study is to determine whether using Taclonex ointment under a hydrogel patch is more effective than using the ointment alone in treating psoriasis. Taclonex ointment is currently FDA approved for use on psoriasis. The hydrogel patch is a type of adhesive pad and contains no medications. It is currently FDA approved and has been shown to be safe and virtually free of side effects. The hypothesis is that psoriatic plaques which are treated with Taclonex ointment under a hydrogel patch will be more effectively treated compared to psoriatic plaques treated with Taclonex alone.
Detailed description
This will be an open label, bilaterally-controlled single center study. Thirty subjects with plaque type psoriasis will be enrolled in the study. All subjects will receive treatment on two target lesions that are similar in erythema, scaling and induration, and symmetric in anatomic location. The severity of their target lesions will be assessed using a modified Psoriasis Area and Severity Index (PASI) scoring system (Appendix A). Symmetrical target lesions must each be rated at a PASI score equal to or greater than 7 and be within 1 PASI score of each other. All subjects will apply Taclonex ointment to both target lesions once daily for 4 weeks. The occlusive dressing will be applied by the subject to one of the two symmetrical target lesions once daily for 4 weeks. The occlusive dressing will be removed by the patient if he/she experiences warmth, irritation, increased erythema, and/or itching. If the patch is removed due to these symptoms and signs, the subject will leave the lesion un-occluded until for 24 hours, at which time a new occlusive dressing will be placed. After the initial 4 weeks of treatment, there will be a follow up period of 6 weeks during which no treatment is used. Subjects will be restricted from using systemic therapies for psoriasis during this study, including Psoralen Ultraviolet A (PUVA) photochemotherapy and herbal therapies. All topical medications, except the study medications, and UVB phototherapy are prohibited on the target lesions. All of the other psoriasis lesions on the body can be treated as usual with other topical medications and Ultraviolet B (UVB) phototherapy as long as it does not impact on the two target lesions.
Interventions
DRUGTaclonex Ointment and Hydrogel Patch
Each patient will have bilateral symmetrical psoriatic plaques. One plaque will be treated with Taclonex Ointment daily along with Hydrogel Patch daily. All treatment will be for 4 weeks.
DRUGTaclonex Ointment
Taclonex ointment daily for one psoriatic plaque.
Sponsors
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has signed the informed consent form and Health Information Portability and Accountability Act (HIPAA) authorization form; 2. Male or female subject at least 18 years of age; 3. A diagnosis of stable plaque-type psoriasis vulgaris with at least one pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equivalent (no more than one point difference) modified Psoriasis Area Severity Index (PASI) scores. Each paired target lesions must have PASI scores equal to or greater than 7; 4. Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis; 5. Psoriasis must be clinically stable for at least 30 days before enrollment; 6. Subject is able to discontinue the use of any medication or therapy for relief of psoriasis in the target areas to be treated; 7. Subject is able to discontinue the use of any systemic medication or therapy (e.g. oral or injectable psoriasis medications, PUVA photochemotherapy, herbal remedies, etc.) for psoriasis; 8. Subject must be reliable and mentally competent to complete study measurements; 9. Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.
Exclusion criteria
1. Subject has a skin disorder other than psoriasis in the target areas to be evaluated; 2. Known hypersensitivity to any component of the test medications; 3. Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters; 4. Clinically infected psoriasis at baseline; 5. Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis; 6. Spontaneously worsening or improving psoriasis within 30 days of enrollment; 7. Any evidence of atrophy in the areas selected for treatment with topical corticosteroid; 8. Topical or intralesional therapies (other than emollients) or UVB phototherapy on potential target lesions within two weeks of starting study treatment; 9. Systemic therapy, PUVA phototherapy, or a systemic investigational therapy for psoriasis within 30 days prior to study entry; 10. Treatment with topical investigational therapy of the target lesions within 30 days prior to study entry; 11. Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators. 12. Subject is pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Modified PASI Score at Week 4 Compared to Baseline | 4 weeks | Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion | 6 Weeks | Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion. |
Countries
United States
Participant flow
Recruitment details
Recruitment took place at the University of California at San Francisco (UCSF) Psoriasis and Skin Treatment Center.
Pre-assignment details
Patients were assessed for psoriasis severity as well as washout from other concomitant medications
Participants by arm
| Arm | Count |
|---|---|
| Ointment + Patch vs. Ointment Alone | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Ointment + Patch vs. Ointment Alone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change in Total Modified PASI Score at Week 4 Compared to Baseline
Modified psoriasis severity index measures erythema, induration, and scaling each measured from 0-4, with a maximum summed score of 12. A higher score means greater psoriasis severity and a lower score means lower psoriasis severity.
Time frame: 4 weeks
Population: The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Taclonex Ointment Occluded With Hydrogel Patch | Change in Total Modified PASI Score at Week 4 Compared to Baseline | 0.86 Units on a scale |
| Taclonex Alone | Change in Total Modified PASI Score at Week 4 Compared to Baseline | 2.2 Units on a scale |
p-value: 0.0008t-test, 2 sided
Secondary
Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion
Change in Modified PASI Scores Between Week 4 and Week 6 During the Follow-up Period. This is to Determine Whether There is Further Improvement of Psoriasis After the Cessation of Occlusion.
Time frame: 6 Weeks
Population: This outcome measure was not analyzed due to termination of the study