Plaque Psoriasis, Psoriasis
Conditions
Keywords
psoriasis, plaque psoriasis, 122-0551, steroid
Brief summary
Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.
Interventions
DRUG122-0551
Applied twice daily for two weeks
DRUGVehicle
Applied twice daily for two weeks
Sponsors
Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a clinical diagnosis of stable plaque psoriasis * Subject has an ODS score for the Treatment Area of 3 or 4 at study start
Exclusion criteria
* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. * Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. * Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start * Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start * Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start * Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start * Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start * Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start * Subject is currently using lithium or Plaquenil (hydroxychloroquine) * Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized * Subject is pregnant, lactating, or is planning to become pregnant during the study * Subject is currently enrolled in an investigational drug or device study * Subject has used an investigational drug or investigational device treatment within 30 days prior to study start * Subject has been previously enrolled in this study and treated with a test article
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Disease Severity (ODS) Score | baseline and Day 15 (End of Study - EOS) | The percentage of subjects with ODS treatment success at EOS where EOS is the subject's last completed visit. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ODS Treatment Success at Day 8 and Day 15 | baseline, Day 8, and Day 15 | The percentage of subjects with ODS treatment success at Day 8 and Day 15. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. |
| ODS Improved at Day 8 and Day 15 | baseline, Day 8, and Day 15 | The percentage of subjects rated improved with respect to ODS at Days 8 and 15. Improved is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe. |
| Treatment Success for Clinical Signs and Symptoms of Psoriasis | baseline, Day 8 and Day 15 | The percentage of subjects rated treatment success for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. Treatment success is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. |
| Improved for Clinical Signs and Symptoms of Psoriasis | baseline, Day 8 and Day 15 | The percentage of subjects rated improved for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. Improved is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe. |
| Change in % Body Surface Area (BSA) With Psoriasis | baseline, Day 8 and Day 15 | Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15. |
Countries
United States
Participant flow
Recruitment details
Recruitment period: May 2012 to September 2012 The location of clinical sites included dermatology clinical research centers.
Pre-assignment details
All subjects who met the entry criteria were randomized and enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| 122-0551 122-0551: Applied twice daily for two weeks | 23 |
| Vehicle Vehicle: Applied twice daily for two weeks | 21 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incarcerated | 0 | 1 |
Baseline characteristics
| Characteristic | 122-0551 | Total | Vehicle |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 14.3 | 50.0 years STANDARD_DEVIATION 14.5 | 48.6 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 35 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 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 | 21 Participants | 40 Participants | 19 Participants |
| Region of Enrollment United States | 23 participants | 44 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 33 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 21 |
| other Total, other adverse events | 1 / 23 | 3 / 21 |
| serious Total, serious adverse events | 0 / 23 | 0 / 21 |
Outcome results
Primary
Change in Overall Disease Severity (ODS) Score
The percentage of subjects with ODS treatment success at EOS where EOS is the subject's last completed visit. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline and Day 15 (End of Study - EOS)
Population: Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 122-0551 | Change in Overall Disease Severity (ODS) Score | 52.2 percentage of participants |
| Vehicle | Change in Overall Disease Severity (ODS) Score | 0.0 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Change in % Body Surface Area (BSA) With Psoriasis
Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.
Time frame: baseline, Day 8 and Day 15
Population: Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 122-0551 | Change in % Body Surface Area (BSA) With Psoriasis | Day 8 | -0.3 Change in percent BSA | Standard Deviation 0.69 |
| 122-0551 | Change in % Body Surface Area (BSA) With Psoriasis | Day 15 | -1.3 Change in percent BSA | Standard Deviation 2.07 |
| Vehicle | Change in % Body Surface Area (BSA) With Psoriasis | Day 8 | 0.0 Change in percent BSA | Standard Deviation 0 |
| Vehicle | Change in % Body Surface Area (BSA) With Psoriasis | Day 15 | 0.0 Change in percent BSA | Standard Deviation 0.32 |
Secondary
Improved for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated improved for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. Improved is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: baseline, Day 8 and Day 15
Population: Analysis shown is the Intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 8) | 26.1 percentage of participants |
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 15) | 73.9 percentage of participants |
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 8) | 0.0 percentage of participants |
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 15) | 34.8 percentage of participants |
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 8) | 4.3 percentage of participants |
| 122-0551 | Improved for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 15) | 56.5 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 8) | 0.0 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 8) | 0.0 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 15) | 0.0 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 15) | 0.0 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 15) | 0.0 percentage of participants |
| Vehicle | Improved for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 8) | 0.0 percentage of participants |
Secondary
ODS Improved at Day 8 and Day 15
The percentage of subjects rated improved with respect to ODS at Days 8 and 15. Improved is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
Population: Analysis shown is the Intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 | ODS Improved at Day 8 and Day 15 | Day 8 | 0.0 percentage of participants |
| 122-0551 | ODS Improved at Day 8 and Day 15 | Day 15 | 52.2 percentage of participants |
| Vehicle | ODS Improved at Day 8 and Day 15 | Day 8 | 0.0 percentage of participants |
| Vehicle | ODS Improved at Day 8 and Day 15 | Day 15 | 0.0 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
ODS Treatment Success at Day 8 and Day 15
The percentage of subjects with ODS treatment success at Day 8 and Day 15. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
Time frame: baseline, Day 8, and Day 15
Population: Analysis shown is the Intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 | ODS Treatment Success at Day 8 and Day 15 | Day 8 | 0.0 percentage of participants |
| 122-0551 | ODS Treatment Success at Day 8 and Day 15 | Day 15 | 52.2 percentage of participants |
| Vehicle | ODS Treatment Success at Day 8 and Day 15 | Day 8 | 0.0 percentage of participants |
| Vehicle | ODS Treatment Success at Day 8 and Day 15 | Day 15 | 0.0 percentage of participants |
p-value: <0.0001Fisher Exact
Secondary
Treatment Success for Clinical Signs and Symptoms of Psoriasis
The percentage of subjects rated treatment success for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. Treatment success is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Time frame: baseline, Day 8 and Day 15
Population: Analysis shown is the Intent-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 8) | 21.7 percentage of participants |
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 15) | 60.9 percentage of participants |
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 8) | 0.0 percentage of participants |
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 15) | 21.7 percentage of participants |
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 8) | 8.7 percentage of participants |
| 122-0551 | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 15) | 56.5 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 8) | 0.0 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 8) | 0.0 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 15) | 0.0 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Scaling (Day 15) | 0.0 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Plaque Elevation (Day 15) | 0.0 percentage of participants |
| Vehicle | Treatment Success for Clinical Signs and Symptoms of Psoriasis | Erythema (Day 8) | 0.0 percentage of participants |