Psoriasis
Conditions
Keywords
chronic plaque psoriasis
Brief summary
This is a 12 week bilateral study, consisting of 6 weeks of treatment and 6 weeks of follow-up. The purpose of the study is to compare the safety and effectiveness of combining and then following a high potency topical corticosteroid treatment with LCD treatment for moderate-to-severe localized plaque psoriasis.
Detailed description
Superpotent topical corticosteroids such as clobetasol propionate are highly effective in treating plaque psoriasis but are not indicated for long term use due to their side effects. Therefore, steroid-sparing combination and sequential regimens, in which the corticosteroid gets supplemented with a non-steroid medication, such as calcipotriol or tazarotene, have become the standard of care, especially in the management of localized psoriasis lesions. A new steroid-free 15% liquor carbonis distillate (LCD) solution (Psorent) was recently found to be more successful than 0.005% calcipotriol cream (Dovonex) at improving and delaying worsening of psoriasis symptoms in a controlled clinical trial. The goal of this pilot study is to evaluate if this LCD solution can be used in combination with acute topical corticosteroid therapy as a new steroid-sparing / enhancing regimen. We hope to explore the compatibility, patient tolerability, and clinical benefit of using LCD solution during and after treatment with clobetasol propionate in adults with moderate to severe plaque psoriasis. This is a randomized, double-blind, vehicle-controlled, bilateral study. Men and women 18 years of age or older, with chronic plaque psoriasis affecting less than or equal to 10% body surface area (BSA) in areas other than the scalp, face, palms, soles, axillae, and groin, are recruited. Those with a Physician Global Assessment (PGA) score greater than 3 and are in general good health will qualify as candidates. On one side of the body, LCD solution and clobetasol propionate will be administered twice daily for the first 2 weeks of treatment, followed by 4 weeks of LCD solution only, followed by 6 weeks of no treatment. On the second half of the body, subject will apply a vehicle solution and clobetasol propionate twice daily for the first 2 weeks, only the vehicle solution twice daily for the next four weeks, and then no treatment for the next 6 weeks. Subjects will be evaluated at weeks 2, 4, 6, 8, 10 and 12. investigators will use the PGA scale \[Clear (0) - Severe (5)\] to determine treatment effects as well as Target Lesion assessments of Erythema, Scaling, Induration and overall severity \[None (0) - Very Severe (4)\]. patients will also be required to complete Self-Assessment questionnaires on their psoriasis \[None (0) - Severe (6)\]. as well as an assessment of the study solution \[Excellent (9) - Poor (1)\]. . Photographs will be taken at each study visit and adverse events will be monitored throughout the study.
Interventions
OTHERPlacebo
One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day
DRUGCorticosteroid
One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day
DRUGLCD
One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day
Sponsors
NeoStrata Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * able to provide written informed consent * able to attend study visits, apply medications, and follow instructions * moderate to severe localized plaque psoriasis lesions (\<10% BSA on each side of the body)
Exclusion criteria
* other current treatments for psoriasis * hypersensitivity to steroids, liquor carbonis detergens, alcohol, fragrance * pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Weeks 2, 6, & 12. | Those patients that have reached a PGA score of zero \[PGA scale: clear (0) - very severe (5)\], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Weeks 2, 6, & 12 | Mean percent improvement in disease severity using Physician Global Assessment (PGA) \[PGA scale: Clear (0) - Very Severe (5)\] and overall severity scores of target lesions (OTLS) \[OTLS scale None (0) - Very Severe (4)\] based on erythema, scaling and induration, at each visit interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid+LCD vs Corticosteroid+Placebo one side of body: corticosteroid and liquor carbonis distillate (LCD) treatment applied twice a day, for 2 weeks, then LCD-only twice a day, for 4 weeks, then no treatment for 6 weeks
opposite side of body: corticosteroid and placebo vehicle solution twice a day, for 2 weeks, then placebo vehicle solution-only twice a day, for 4 weeks, then no treatment for 6 weeks | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Corticosteroid + LCD/ +Placebo (2 Weeks) | Adverse Event | 1 | 0 |
| Corticosteroid + LCD/ +Placebo (2 Weeks) | Lost to Follow-up | 0 | 1 |
| No Treatment (6 Weeks) | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | Corticosteroid+LCD vs Corticosteroid+Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit.
Those patients that have reached a PGA score of zero \[PGA scale: clear (0) - very severe (5)\], and are considered clear of chronic plaque psoriasis, or have reached a PGA score of 1, with minimal disease at each visit, in each condition. Data was collected at weeks 2, 6 and 12.
Time frame: Weeks 2, 6, & 12.
Population: All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Corticosteroid + LCD | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 2 | 33.3 percentage of participants |
| Corticosteroid + LCD | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 6 | 46.2 percentage of participants |
| Corticosteroid + LCD | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 12 | 25.0 percentage of participants |
| Corticosteroid + Placebo | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 2 | 6.7 percentage of participants |
| Corticosteroid + Placebo | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 6 | 15.4 percentage of participants |
| Corticosteroid + Placebo | Percentage of Patients Who Are Clear (PGA Score 0) or Have Minimal Disease (PGA Score 1) on Each Treated Side at Each Visit. | Percentage with PGA scores ≤ 1 at Week 12 | 16.7 percentage of participants |
Secondary
Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions
Mean percent improvement in disease severity using Physician Global Assessment (PGA) \[PGA scale: Clear (0) - Very Severe (5)\] and overall severity scores of target lesions (OTLS) \[OTLS scale None (0) - Very Severe (4)\] based on erythema, scaling and induration, at each visit interval.
Time frame: Weeks 2, 6, & 12
Population: All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 12 | 31 Mean Percent Improvement |
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 2 | 43 Mean Percent Improvement |
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 2 | 39 Mean Percent Improvement |
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 6 | 47 Mean Percent Improvement |
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 6 | 46 Mean Percent Improvement |
| Corticosteroid + LCD | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 12 | 29 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 6 | 20 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 12 | 12 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 6 | 25 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 2 | 43 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of OTLS score at Week 12 | 7 Mean Percent Improvement |
| Corticosteroid + Placebo | Mean Percent Improvement in Disease Severity Using PGA and OTLS Scores of Target Lesions | Percent improvement of PGA score at Week 2 | 34 Mean Percent Improvement |