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Topical Steroid-Retinoid Combination
Duobrii for Acne Keloidalis Nuchae
Phase 3
Recruiting
Led By Cula Svidzinski, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 baseline and week 12
Awards & highlights
Study Summary
This trial will evaluate the effectiveness of Duobrii for the treatment of AKN. Patients will be monitored over 3 months to measure improvement in symptoms.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Duobrii may cause skin irritation or reactions at the application site due to its steroid-retinoid components. Other potential side effects could include changes in skin coloration or texture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in lesion count classification
Secondary outcome measures
Changes in Itch Rating Scale
Changes in Pain Rating Scale
Changes in degree of dyspigmentation
Trial Design
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
Find a Location
Who is running the clinical trial?
Bausch Health Americas, Inc.Industry Sponsor
262 Previous Clinical Trials
81,998 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,446 Total Patients Enrolled
Cula Svidzinski, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am currently using or have used minoxidil in the last 3 months.I have an autoimmune disease, thyroid disorder, or am sensitive to steroids.I have used Duobrii for scalp conditions.I am using or willing to use approved birth control methods if of childbearing potential, or I am not able to have children.I have had steroid injections for AKN in the last 6 months.I am 18 years old or older.I haven't taken medication for acne or hair loss in the last 6 months.I have a history of scalp or hair diseases, including different types of hair loss.The size of your AKN is smaller than 6.5 cm.
Research Study Groups:
This trial has the following groups:- Group 1: Duobrii
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pilaris Keratosis Patient Testimony for trial: Trial Name: NCT05608499 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have any patients signed up for this research project yet?
"According to the latest information available on clinicaltrials.gov, this trial is still recruiting patients. The posting went up on October 4th, 2020 and was last updated a month ago on November 1st, 2020."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have 10 kelloids. I have had one cut 2 times but it has re-emerged even bigger. The other 9 are steadily growing. These scars have been my major cause of social anxiety.
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Icahn School of Medicine at Mount Sinai: < 48 hours
Typically responds via
Email
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