Plaque Psoriasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEnstilar
Enstilar foam applied to affected area once daily
Sponsors
Derm Research, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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. \[Exception: Female subjects of child bearing potential (CBP) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\] 2. Moderate plaque type psoriasis eligible for topical therapies. 3. Patients with a minimum of 3% BSA to a maximum of 20% BSA & bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter. 4. Physician Global Assessment (PGA) score of 3. 5. Able to understand study requirements and sign Informed Consent/HIPAA forms. \-
Exclusion criteria
1. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study. 2. History of hypercalcaemia or vitamin D toxicity. 3. Patients with guttate, erythrodermic, or pustular psoriasis 4. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.) 5. Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline. 6. Use of any biologics within 3 months of baseline. 7. Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate, cyclosporine, or other immunomodulators) within 4 weeks of baseline. 8. Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks of baseline. 9. Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations of psoriasis. 10. Known hypersensitivity to Enstilar or any of its components. 11. Contraindications according to Enstilar. 12. Current drug or alcohol abuse (Investigator opinion.) 13. Subject unable to commit to all the assessments required by protocol. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | screening/baseline, week 2, week 4 | Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lesion Size From Baseline to Week 2 and Week 4 | screening/baseline, week 2, week 4 | Size of target lesion recorded as height in cm x length in cm |
| Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 | screening/baseline, week 2, 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%) |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | screening/baseline, week 2, week 4 | 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 |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | screening/baseline, week 2, week 4 | 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 |
| Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | screening/baseline, week 2, week 4 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Enstilar Foam | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Age, Continuous | 53 years STANDARD_DEVIATION 16 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 20 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Time frame: screening/baseline, week 2, week 4
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 4 | Moderate | 1 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 4 | Mild | 4 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Baseline | Moderate | 20 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Baseline | Mild | 0 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Baseline | Almost Clear | 0 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Baseline | Clear | 0 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 2 | Moderate | 1 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 2 | Mild | 13 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 2 | Almost Clear | 6 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 2 | Clear | 0 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 4 | Almost Clear | 9 Participants |
| Enstilar Foam | Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 | Week 4 | Clear | 6 Participants |
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%)
Time frame: screening/baseline, week 2, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enstilar Foam | Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 | Baseline | 9.8 percentage of body covered by psoriasis | Standard Deviation 6.8 |
| Enstilar Foam | Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 | Week 2 | 9.2 percentage of body covered by psoriasis | Standard Deviation 6.9 |
| Enstilar Foam | Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4 | Week 4 | 6.9 percentage of body covered by psoriasis | Standard Deviation 7.5 |
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
Time frame: screening/baseline, week 2, week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enstilar Foam | Change in Lesion Size From Baseline to Week 2 and Week 4 | Week 4 | 10 cm^2 | Standard Deviation 8 |
| Enstilar Foam | Change in Lesion Size From Baseline to Week 2 and Week 4 | Baseline | 19 cm^2 | Standard Deviation 14 |
| Enstilar Foam | Change in Lesion Size From Baseline to Week 2 and Week 4 | Week 2 | 16 cm^2 | Standard Deviation 13 |
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
Time frame: screening/baseline, week 2, week 4
Population: Erythema assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 8 Extremely Red | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 6 Very Red | 5 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 4 Red | 13 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 2 Pink | 2 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 1 Slightly Pink | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Baseline | 0 None | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 8 Extremely Red | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 6 Very Red | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 4 Red | 4 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 2 Pink | 14 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 1 Slightly Pink | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 2 | 0 None | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 8 Extremely Red | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 6 Very Red | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 4 Red | 4 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 2 Pink | 7 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 1 Slightly Pink | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema | Week 4 | 0 None | 8 Participants |
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
Time frame: screening/baseline, week 2, week 4
Population: Induration assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 2 Slight | 8 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 6 Marked | 5 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 4 Moderate | 13 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 3 Mild | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 2 Slight | 2 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 1 Very Slight | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Baseline | 0 None | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 6 Marked | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 4 Moderate | 3 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 3 Mild | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 2 Slight | 9 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 1 Very Slight | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 2 | 0 None | 6 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 6 Marked | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 4 Moderate | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 3 Mild | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 1 Very Slight | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration | Week 4 | 0 None | 11 Participants |
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)
Time frame: screening/baseline, week 2, week 4
Population: Scaling assessment
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Baseline | 8 Very Severe | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Baseline | 6 Severe | 7 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Baseline | 4 Moderate | 12 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Baseline | 2 Mild | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Baseline | 0 None | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 2 | 8 Very Severe | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 2 | 6 Severe | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 2 | 4 Moderate | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 2 | 2 Mild | 10 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 2 | 0 None | 9 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 4 | 8 Very Severe | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 4 | 6 Severe | 0 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 4 | 4 Moderate | 1 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 4 | 2 Mild | 4 Participants |
| Enstilar Foam | Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling | Week 4 | 0 None | 15 Participants |