This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.
Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study. Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle 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 who have been started on commercial Otezla in the last 7 days will be randomized to study treatment as outlined above. Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There will be standard medication/treatment and washout periods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Center for Dermatology and Laser Surgery
Sacramento, California, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Lawrence J. Green, MD LLC
Rockville, Maryland, United States
Dermatology & Laser Center of Charleston
Charleston, South Carolina, United States
Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=\<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs)
Time frame: 16 weeks
Percent of Subjects With PASI 75 at Week 4 and Week 12
Psoriasis Area \& Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)
Time frame: 4 weeks, 12 weeks
Percent of Subjects With PASI 90 and 100 at Week 16
Psoriasis Area \& Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)
Time frame: 16 weeks
Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 weeks, 12 weeks, 16 weeks
Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome.
Time frame: 4 weeks, 12 weeks, 16 weeks
Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life.
Time frame: 4 weeks, 12, weeks, 16 weeks