Duobrii for Acne Keloidalis Nuchae
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Duobrii, a topical treatment, to determine its effectiveness for early-mild acne keloidalis nuchae (AKN), a skin condition causing scarring on the back of the scalp. The goal is to see if Duobrii reduces the number of lesions more effectively than a placebo. Men of African descent with AKN, whose lesions are less than 6.5 cm wide and who have not used certain treatments in the past, might be suitable for this study. Participants will attend regular check-ups to monitor their progress. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications. The trial excludes those who have used topical steroids on their scalp in the last 4 weeks, systemic medications for AKN or acne in the last 6 months, and those currently using systemic steroids or immunosuppressants.
Is there any evidence suggesting that Duobrii is likely to be safe for humans?
Research has shown that Duobrii has undergone thorough safety studies. It is the only FDA-approved treatment that combines a strong steroid with a retinoid for skin conditions. In past studies, most participants tolerated it well.
However, some side effects have occurred. The most common include skin irritation in about 7% of users, pain at the application site in 3%, and inflamed hair follicles in 2%. Other less common effects are skin thinning and itching, each affecting about 2% of users.
These findings suggest that while Duobrii is generally safe, a small number of people might experience mild to moderate skin reactions.12345Why do researchers think this study treatment might be promising for AKN?
Most treatments for Acne Keloidalis Nuchae, like corticosteroids and surgical options, focus on reducing inflammation and removing affected tissue. However, Duobrii is unique because it combines halobetasol propionate and tazarotene, offering both anti-inflammatory and retinoid benefits in one formulation. This dual approach not only aims to reduce inflammation but also helps in skin renewal and possibly better long-term outcomes. Researchers are excited about Duobrii because it may provide a more comprehensive treatment option that addresses multiple aspects of the condition, potentially leading to superior results compared to current therapies.
What evidence suggests that Duobrii might be an effective treatment for acne keloidalis nuchae?
Research has shown that Duobrii, a combination of a strong steroid and a retinoid, may help treat acne keloidalis nuchae (AKN), a type of scarring skin condition. In one study, patients experienced a 34% improvement in symptoms after 8 weeks and a 49% improvement after 16 weeks. These benefits persisted for at least two months after stopping the treatment. The FDA has already approved Duobrii for skin use, making it a trusted option for treating skin problems. In this trial, participants will receive either Duobrii or a placebo to evaluate its effectiveness in managing early to mild cases of AKN.16789
Who Is on the Research Team?
Benjamin Ungar
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Duobrii for the management of early-mild AKN with visits at baseline, 4 weeks, 8 weeks, and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Duobrii
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Bausch Health Americas, Inc.
Industry Sponsor
Dr. Jonathan Sadeh
Bausch Health Americas, Inc.
Chief Medical Officer
MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School
Thomas J. Appio
Bausch Health Americas, Inc.
Chief Executive Officer since 2021
Bachelor's degree in Biology from Rutgers University
Citations
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication.
Acne Keloid - Drugs, Targets, Patents
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN). 100 Clinical Results associated with Acne Keloid. Login to view more data.
Treatment of Acne Keloidalis Nuchae: A Systematic ...
A significant improvement was noted on the treated side by 34% at 8 weeks and 49% at 16 weeks. The results were maintained at 2-months follow-up ...
Duobrii (halobetasol/tazarotene) Trials
Trial + Data / Events, Status, Ph, N, Region, Interventions, Sponsor ... NCT05608499: Duobrii Treatment of Acne Keloidalis Nuchae (AKN). Terminated. 3.
Duobrii Treatment of Acne Keloidalis Nuchae (AKN) - ICH GCP
Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are ...
proven safety and tolerability
The most common adverse reactions are contact dermatitis (7%), application site pain (3%), folliculitis (2%), skin atrophy (2%), and excoriation (2%).
TITLE OF RESEARCH STUDY:
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN). PI: Benjamin Ungar. NCT05608499. Document Date: 7/30/2024. Page 2. THE MOUNT ...
DUOBRII™ (halobetasol propionate - accessdata.fda.gov
DUOBRII Lotion is contraindicated in pregnancy [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].]. 5 WARNINGS AND ...
Duobrii (halobetasol/tazarotene) Trials
NCT05608499: Duobrii Treatment of Acne Keloidalis Nuchae (AKN). Terminated. 3 ; 2019-002406-43: Absorption and effect on defined hormones of IDP-118 lotion, ...
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