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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid + LCD | Experimental | corticosteroid and LCD treatment (2 weeks), LCD alone treatment (4 weeks) |
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| Corticosteroid + Placebo | Placebo Comparator | corticosteroid and placebo treatment (2 weeks), placebo alone treatment (4 weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | One side of body: clobetasol: 2 applications / day along with LCD application 2 applications/day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 2, 6, & 12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 2, 6, & 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Bagel, MD | Psoriasis Treatment Center of Central New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windsor Dermatology | East Windsor | New Jersey | 08520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid + LCD (Left), Corticosteroid + Placebo (Right) | Corticosteroid + LCD on left side of body, Corticosteroid + Placebo on right side of body (n=7). On left side: Corticosteroid + 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 On right side: 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 |
| FG001 | Corticosteroid + LCD (Right), Corticosteroid + Placebo (Left) | Corticosteroid + LCD on right side of body, Corticosteroid + Placebo on left side of body (n=8). On right side: Corticosteroid + 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 On left side: 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Corticosteroid + LCD/ +Placebo (2 Weeks) |
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| +LCD / +Placebo Only (4 Weeks) |
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| No Treatment (6 Weeks) |
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Fifteen patients with localized chronic plaque psoriasis (less than or equal to 6% BSA and PGA score greater than or equal to 3) were enrolled. Eleven patients completed the study. Three patients were removed due to an adverse event, and 1 patient was lost to follow-up after week 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward. | Posted | Number | percentage of participants | Weeks 2, 6, & 12. |
|
Adverse event information was monitored throughout the entire 12 week study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Corticosteroid + LCD | Corticosteroid + LCD solution applied to one side of body twice per day for 2 weeks. Then, LCD solution- only applied to one side of the body twice per day for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | One subject was removed from the study due to a treatment-related adverse event involving contact dermatitis with clobetasol, LCD, and vehicle with bilateral itching. |
This was a bilateral study in which 15 subjects total were recruited and randomized to receive both interventions simultaneously by dividing treatment arms to each side of the body.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Green, RPH, MS | NeoStrata Co., Inc. | (609) 520-0715 | bgreen@neostrata.com |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D002990 | Clobetasol |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001623 | Betamethasone |
| D013259 | Steroids, Fluorinated |
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| Placebo | Other | One side of body: Placebo Solution: 2 applications / day along with clobetasol 2 applications/day |
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| LCD | Drug | One side of body: LCD Solution: 2 applications / day along with clobetasol 2 applications/day |
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| NOT COMPLETED |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Corticosteroid + Placebo |
Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks. |
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| 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. | All randomized patients were included in analyses. Missing scores within each study phase only were filled in by last observation carried forward. | Posted | Mean | Full Range | Mean Percent Improvement | Weeks 2, 6, & 12 |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Corticosteroid + Placebo | Corticosteroid + placebo applied to one side of body twice per day for 2 weeks. Then, placebo-only applied to one side of the body twice per day for 4 weeks. | 0 | 15 | 1 | 15 |
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| Bilateral Worsening of Plaque Psoriasis | Skin and subcutaneous tissue disorders | Systematic Assessment | Two subjects were removed from the study due to treatment-related bilateral worsening of their psoriasis. |
|
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| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Percent improvement of PGA score at Week 12 |
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| Percent improvement of OTLS score at Week 2 |
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| Percent improvement of OTLS score at Week 6 |
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| Percent improvement of OTLS score at Week 12 |
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