NCT03848871

The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Derm Research, PLLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Enstilar	Enstilar foam applied to affected area once daily

Timeline

• Start date: 2017-12-12
• Primary completion: 2018-11-30
• Completion: 2018-12-10
• First posted: 2019-02-21
• Last updated: 2020-08-26
• Results posted: 2020-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study