Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.
Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.
NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enstilar foam | Experimental | Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enstilar | Drug | Enstilar foam applied to affected area once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate | screening/baseline, week 2, week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Size From Baseline to Week 2 and Week 4 | Size of target lesion recorded as height in cm x length in cm | screening/baseline, week 2, week 4 |
| Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 |
Not provided
Inclusion Criteria:
Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-) urine pregnancy test (UPT) result within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study.
A female is considered of childbearing potential unless she is:
- postmenopausal >5 years, without a uterus and/or both ovaries, or has been surgically sterile for >6 months
Reliable methods of contraception are:
- hormonal methods or intrauterine device (IUD) in use > 90 days prior to study drug administration, barrier methods plus spermicide in use > 14 days prior, or vasectomized partner.
[Exception: Female subjects of child bearing potential (CBP) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]
Moderate plaque type psoriasis eligible for topical therapies.
Patients with a minimum of 3% BSA to a maximum of 20% BSA & bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
Physician Global Assessment (PGA) score of 3.
Able to understand study requirements and sign Informed Consent/HIPAA forms.
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Enstilar Foam | Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. Enstilar: Enstilar foam applied to affected area once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enstilar Foam | Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. Enstilar: Enstilar foam applied to affected area once daily |
| 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 | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate | Posted | Count of Participants | Participants | screening/baseline, week 2, week 4 |
|
|
4 weeks average, from signing of Informed consent until end of study participation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enstilar Foam | Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. Enstilar: Enstilar foam applied to affected area once daily |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GERD exacerbation | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen McAllister | Skin Sciences, PLLC | 5024519000 | mmdermresearch@yahoo.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2018 | Feb 6, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C517164 | betamethasone dipropionate, calcipotriol drug combination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%)
| screening/baseline, week 2, week 4 |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion | screening/baseline, week 2, week 4 |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion | screening/baseline, week 2, week 4 |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion) | screening/baseline, week 2, week 4 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change in Lesion Size From Baseline to Week 2 and Week 4 | Size of target lesion recorded as height in cm x length in cm | Posted | Mean | Standard Deviation | cm^2 | screening/baseline, week 2, week 4 |
|
|
|
| Secondary | Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 | Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%) | Posted | Mean | Standard Deviation | percentage of body covered by psoriasis | screening/baseline, week 2, week 4 |
|
|
|
| Secondary | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion | Erythema assessment | Posted | Count of Participants | Participants | screening/baseline, week 2, week 4 |
|
|
|
| Secondary | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion | Induration assessment | Posted | Count of Participants | Participants | screening/baseline, week 2, week 4 |
|
|
|
| Secondary | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion) | Scaling assessment | Posted | Count of Participants | Participants | screening/baseline, week 2, week 4 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| dry cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| 2 Pink |
|
| 1 Slightly Pink |
|
| 0 None |
|
| Week 2 |
|
| Week 4 |
|
| 2 Slight |
|
| 1 Very Slight |
|
| 0 None |
|
| Week 2 |
|
| Week 4 |
|
| 2 Mild |
|
| 0 None |
|
| Week 2 |
|
| Week 4 |
|