Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03441789|
Recruitment Status : Completed
First Posted : February 22, 2018
Results First Posted : March 13, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Enstilar Drug: Vehicle Drug: Otezla||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||October 1, 2018|
|Actual Study Completion Date :||October 22, 2018|
Experimental: Otezla plus Enstilar foam
Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily
Enstilar foam applied to affected areas daily
Other Name: calcipotriene and betamethasone dipropionate
Placebo Comparator: Otezla plus vehicle foam
Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily
vehicle foam applied to affected areas once daily
- Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16 [ Time Frame: 16 weeks ]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)
- Percent of Subjects With PASI 75 at Week 4 and Week 12 [ Time Frame: 4 weeks, 12 weeks ]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.)
- Percent of Subjects With PASI 90 and 100 at Week 16 [ Time Frame: 16 weeks ]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.)
- Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16 [ Time Frame: 4 weeks, 12 weeks, 16 weeks ]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
- Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16 [ Time Frame: 4 weeks, 12 weeks, 16 weeks ]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.
- Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16 [ Time Frame: 4 weeks, 12, weeks, 16 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441789
|United States, California|
|Center for Dermatology and Laser Surgery|
|Sacramento, California, United States, 95819|
|United States, Kentucky|
|Skin Sciences, PLLC|
|Louisville, Kentucky, United States, 40217|
|United States, Maryland|
|Lawrence J. Green, MD LLC|
|Rockville, Maryland, United States, 20850|
|United States, South Carolina|
|Dermatology & Laser Center of Charleston|
|Charleston, South Carolina, United States, 29414|