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Topical medication

Duobrii Lotion for Plaque Psoriasis

Phase 3

Waitlist Available

Led By Edward Lain, MD, MBA

Research Sponsored by Austin Institute for Clinical Research

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 28 weeks

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test a new cream for people with mild plaque psoriasis to see if it is safe and effective.

Eligible Conditions

Plaque Psoriasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment Success by Percent Investigators Global Assessment (IGA)

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment Group BExperimental Treatment2 Interventions

Subjects whose baseline Itch and/or Burning/Stinging Score is greater than or equal to 2 (moderate), in addition to one tube of Duobrii along with one jar of CeraVe cream, the participant will be given a tube of hydrocortisone 1% cream and instructed to apply to the treatment area twice daily for 5 days, along with CeraVe cream. Starting at day 6 and ongoing, subjects will be instructed to discontinue the hydrocortisone cream and initiate Duobrii application every night, while continuing the CeraVe cream twice daily.

Group II: Treatment Group AExperimental Treatment2 Interventions

Subjects whose baseline Itch and/or Burning/Stinging Score is less than 2 (moderate), one tube of Duobrii along with one jar of CeraVe cream, will be dispensed to the subject at the Baseline visit. The study participant will be instructed to apply the CeraVe cream to the treatment area twice daily and advised to apply a thin layer of the Duobrii only to the affected skin once daily in the evening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meradimate

FDA approved

Ulobetasol

FDA approved

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