Duobrii for Acne Keloidalis Nuchae

Overseen By Savina Sikand

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Systemic steroids, Immunosuppressants

Disqualifiers: Pregnancy, Auto-immune disease, Thyroid disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

30 Participants Needed

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.

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.

How does the drug Duobrii differ from other treatments for acne keloidalis nuchae?

Duobrii is unique because it combines two active ingredients, halobetasol propionate (a strong anti-inflammatory steroid) and tazarotene (a retinoid that helps with skin cell turnover), which may offer a novel approach to treating acne keloidalis nuchae compared to traditional treatments like topical steroids or antibiotics. This combination could potentially address both inflammation and abnormal skin growth, which are key issues in this condition. ^{1 2 3 4 5}

Research Team

Benjamin Ungar

Principal Investigator

Icahn School of Medicine at Mount Sinai

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.

Inclusion Criteria

I am using or willing to use approved birth control methods if of childbearing potential, or I am not able to have children.

Subject is able to provide written informed consent and comply with the requirements of this study protocol

The size of your AKN is smaller than 6.5 cm.

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 am currently using or have used minoxidil in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Duobrii for the management of early-mild AKN with visits at baseline, 4 weeks, 8 weeks, and 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Duobrii Experimental Treatment 2 Interventions

Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Bausch Health Americas, Inc.

Industry Sponsor

Trials

265

Recruited

82,000+

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Innovative Surgical Approaches and Selection Criteria of Large Acne Keloidalis Nuchae Lesions. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective Controlled Trial for the Treatment of Acne Keloidalis Nuchae With a Long-Pulsed Neodymium-Doped Yttrium-Aluminum-Garnet Laser. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Improving acne keloidalis nuchae with targeted ultraviolet B treatment: a prospective, randomized, split-scalp comparison study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acne keloidalis in females: case report and review of literature. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Surgical excision of acne keloidalis nuchae with secondary intention healing. [2022]