Plaque Psoriasis
Conditions
Keywords
psoriasis
Brief summary
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.
Detailed description
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.
Interventions
OTHERLCD Solution with NB-UVB Phototherapy
LCD Solution: 2 applications / day NB-UVB Phototherapy: 3 light sessions / week
DEVICENB-UVB Light Device (311-315 nm)
NB-UVB Phototherapy: 3 light exposures / week
Sponsors
NeoStrata Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * able and willing to provide written informed consent * symmetrical plaque psoriasis * able and willing to attend phototherapy sessions and apply LCD at home * negative pregnancy test for women of child-bearing potential
Exclusion criteria
* current or recent other treatments for psoriasis * hypersensitivity to LCD or UVB light * current or previous skin cancer * pregnant or nursing mother * participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 weeks of treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | 12 weeks of treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | NB-UVB Alone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 44.41 years |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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).
Time frame: 12 weeks of treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| NB-UVB Alone | 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. | Percent Change in PGA score from Baseline | 77.8 percent improvement from baseline |
| NB-UVB Alone | 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. | Mean Percent Change in Erythema | 88.5 percent improvement from baseline |
| NB-UVB Alone | 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. | Mean Percent Change in Induration | 84.2 percent improvement from baseline |
| NB-UVB Alone | 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. | Mean Percent Decrease in Desquamation | 65.2 percent improvement from baseline |
| LCD+NB-UVB | 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. | Mean Percent Decrease in Desquamation | 82.6 percent improvement from baseline |
| LCD+NB-UVB | 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. | Percent Change in PGA score from Baseline | 85.4 percent improvement from baseline |
| LCD+NB-UVB | 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. | Mean Percent Change in Induration | 85.7 percent improvement from baseline |
| LCD+NB-UVB | 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. | Mean Percent Change in Erythema | 88.9 percent improvement from baseline |
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.
Time frame: 12 weeks of treatment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NB-UVB Alone | The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | 3 participants |
| LCD+NB-UVB | The Difference in Number and Severity of Treatment-related Adverse Reactions Between Conditions. | 3 participants |