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The purpose of this study is to determine if combining a daily at-home regimen using an LCD Solution with a 3 times weekly outpatient narrowband UVB phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.
Use of coal tar with narrowband (NB) ultraviolet B (UVB) light (the Goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. This study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (LCD) (coal tar) solution to standard NB_UVB phototherapy in adults with chronic plaque psoriasis. Patients will apply LCD solution to half the body, twice daily at home and receive outpatient full-body NB-UVB light therapy 3 times a week for up to 12 weeks. A blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. Patients will rate their psoriasis symptoms and LCD solution aesthetics. Incorporating an at-home regimen with a novel LCD solution into outpatient NB-UVB light therapy is safe, convenient, and effective and can improve psoriasis more quickly than NB-UVB light therapy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB-UVB Light Device (311-315 nm) | Active Comparator | the subject will receive full body NB-UVB light therapy |
|
| LCD Solution with NB-UVB Phototherapy | Experimental | on half of the body will receive LCD while the full body receives NB-UVB therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCD Solution with NB-UVB Phototherapy | Other | LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. | Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe). | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone. | 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Bagel, MD | Windsor Dermatology, East Windsor, NJ 08520 | 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 | NB-UVB and NB-UVB+LCD | NB-UVB Alone: NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy: 3 light exposures / week NB-UVB+LCD: 2 applications of LCD/day + NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy 3 light exposures / week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
12 participants with bilateral, symmetrical plaque psorasis
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| ID | Title | Description |
|---|---|---|
| BG000 | NB-UVB Alone | One leg receives NB-UVB Alone: NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week Opposite leg receives: LCD therapy 2 applications/day and NB-UVB Light Device (311-315 nm) NB-UVB Phototherapy 3 light exposures / week |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Difference in Bilateral Static Physician's Global Assessment (sPGA) Scores, and Erythema, Scaling, and Induration (ESI) Scores of Bilateral Target Lesion Scores Across Visits for Each Condition and Between Conditions. | Twelve (12) participants were followed over a 12-week treatment period. Treatment was administered bilaterally as they applied LCD solution to one half of their body while receiving full-body NB-UVB light therapy. The difference in their sPGA, and ESI scores of bilateral target lesions were measured across all visits. PGA scores are calculated using a 6-point scale from 0 (clear) to 5 (very severe). Erythema, induration and scaling scores use a 5-point scale from 0 (none) to 4 (very severe). | Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores we filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05. | Posted | Mean | Full Range | percent improvement from baseline | 12 weeks of treatment |
|
Adverse events for this study were monitored and documented throughout the entire 12 week study.
Adverse events were reported directly by the subject to the principal investigator, who then informed the responsible party: NeoStrata Co., Inc.
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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 | NB-UVB Alone | NB-UVB Alone NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | adverse reaction consisted of one report of mild post-NB-UVB erythema, which appeared uniformly on both sides of the body, regardless of treatment condition. |
This is a bilateral pilot study including 12 subjects. Subjects will apply the liquor carbonis distillate (LCD) solution to one half of their body, while receiving narrow-band ultraviolet B (NB-UVB) light therapy across their whole body.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry Bagel, MD | Psoriasis Treatment Center of Central New Jersey | 609-443-4501 | dreamacres1@aol.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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|
| NB-UVB Light Device (311-315 nm) | Device | NB-UVB Phototherapy: 3 light exposures / week |
|
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| NB-UVB Alone |
NB-UVB Alone NB-UVB Light Device (311-315 nm): NB-UVB Phototherapy: 3 light exposures / week |
| OG001 | LCD+NB-UVB | LCD+NB-UVB LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week |
|
|
| Secondary | The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | Number of subjects who experienced and adverse reaction due to UVB + LCD, versus number of subjects who experienced an adverse reaction due to UVB therapy alone. | Data were analyzed using an intent-to-treat (ITT) population. All enrolled patients were included in the analysis. Missing scores were filled in by last observation carried forward method. All statistical tests were two-sided and used a level of significance of alpha = 0.05. | Posted | Number | participants | 12 weeks of treatment |
|
|
|
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | LCD+NB-UVB | LCD+NB-UVB LCD Solution with NB-UVB Phototherapy: LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week | 0 | 12 | 3 | 12 |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Treatment-related adverse reactions consisted of two reports of moderate post-UVB erythema which appeared uniformly on both sides of the body. |
|
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