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Topical Agent
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
Phase 4
Waitlist Available
Research Sponsored by Derm Research, PLLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening/baseline, week 2, week 4
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Approved for 10 Other Conditions
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.
Eligible Conditions
- Plaque Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening/baseline, week 2, week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening/baseline, week 2, week 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Secondary study objectives
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Change in Lesion Size From Baseline to Week 2 and Week 4
Erythema
+2 moreSide effects data
From 2018 Phase 4 trial • 28 Patients • NCT0344178914%
upper respiratory infection
7%
hypertension
7%
compressed lumbar disc
7%
headache
7%
right ankle pain
7%
nausea
7%
dry cough
7%
bronchitis
7%
frequent muscle fasciculation right lower eyelid
7%
abrasion right shin
7%
sensation of fullness in neck
7%
generalized rash
7%
root canal
7%
persistent lower extremity edema
7%
increased joint pain generalized
7%
intertrigo
7%
right lower jaw pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Otezla Plus Vehicle Foam
Otezla Plus Enstilar Foam
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Enstilar foamExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calcipotriol
FDA approved
Find a Location
Who is running the clinical trial?
Derm Research, PLLCLead Sponsor
17 Previous Clinical Trials
552 Total Patients Enrolled