Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Icahn School of Medicine at Mount Sinai
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests Duobrii cream on men of African descent with early-mild AKN. The cream reduces inflammation and helps the skin renew itself, aiming to improve the condition of their skin. Duobrii is a new treatment for moderate to severe plaque psoriasis in adults.
Eligibility Criteria
This trial is for men and women over 18 with early-mild AKN (less than 6.5 cm wide). Women must not be pregnant, breastfeeding, or planning to become pregnant and should use birth control. Participants need to be in good health and haven't used certain medications for AKN, hair loss, or other scalp conditions recently.Exclusion Criteria
I am currently taking steroids or other drugs that weaken my immune system.
I haven't used any topical steroids or medications on my scalp in the last 4 weeks.
I have an autoimmune disease, thyroid disorder, or am sensitive to steroids.
I have used Duobrii for scalp conditions.
Treatment Details
Researchers are testing Duobrii's effectiveness on early-mild AKN compared to a placebo and Bryhali. Patients will have scheduled visits over a period of 12 weeks where their symptoms will be assessed through surveys, photos, and clinical evaluations.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DuobriiExperimental Treatment2 Interventions
Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Research locations nearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Bausch Health Americas, Inc.Industry Sponsor