Plaque Psoriasis Clinical Trial
Official title:
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
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.
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