Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.

Study Overview

• Status: Terminated
• Conditions: Acne Keloidalis Nuchae; AKN
• Intervention / Treatment: Drug: Duobrii; Drug: Bryhali; Drug: Placebo

Detailed Description

Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts.

Enrolled participants will be instructed to apply placebo (n=10) vs. active (n=20) to affected area of the occipital scalp for 4 weeks once a day (label use). Each application will be approximately 1g. Following the 4 weeks, participants will be instructed to increase application to twice daily (BID; off-label; at least 8 hours apart) for one week. Investigators will conduct a phone visit on week 5 to discuss any potential side effects with this increased dose. If tolerated, this BID regimen will be carried throughout the length of the study. If BID is not tolerated (if irritation occurs), then Bryhali will be used as a "rescue treatment" once daily for 1 week before the subject returns to BID treatment with Duobrii. If irritation recurs, subjects will be instructed to alternate Duobrii and Bryhali (ie Duobrii BID one day, followed by Bryhali QD the next day, Duobrii BID the next, and so on). Alternating topical steroid use and stepping down topical steroid strength have been known to reduce lesion count in AKN.3 If irritation continues to persist, then participants will be instructed to use Bryhali QD for five days a week and Duobrii BID two days a week. If participants still experience irritation with this regimen, then subjects will be transitioned entirely to Bryhali QD for the remainder of the study. In case of clearance earlier than the end of the study, participants will be instructed to continue their respective regimen to completion of the study. Gentle hair care regimen will be recommended for duration of the length of the study; with unscented shampoo & conditioner (such as Head & shoulder) and Vaseline to scalp as moisturizer to minimize risk of contact dermatitis. In addition, patients will be instructed to postpone any form of hair coloring or chemical hair processing until after the study is over.

Participants will be followed with visits scheduled at baseline, 4 weeks, 8 weeks and 12 weeks. At each visit, participants will complete surveys regarding the severity of AKN's associated symptoms (pain, pruritus, burning etc.) as well as the dermatology quality of life index (DLQI) and numerical rating scale (NRS) surveys (Appendix B&D). In addition, photographs will also be obtained for global assessment and lesion count will be performed. The investigator will assess the treatment area for any dyspigmentation and document the % area affected within the treatment area at each visit. Tape strips will also be collected from lesional (occipital scalp) and non-lesional (frontal scalp) at Baseline and Week 12. There will be a phone call visit at week 5 to assess tolerance of medication increase and a safety follow-up visit at Week 14. Statistical analysis will be performed. Throughout the length of the study, any adverse events (AEs) related to the treatment will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subject at least 18 years of age
• Subject is able to provide written informed consent and comply with the requirements of this study protocol
• Subjects have AKN class I or II (less than 6.5 cm in width)

• Subjects who are women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 6 months after the last dose of study. Acceptable methods of birth control include:

  • intrauterine device (IUD) oral;
  • transdermal;
  • implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study);
  • tubal ligation;
  • abstinence;
  • barrier methods with spermicide.

• If not of child-bearing potential, subjects must have:

  • a sterile or vasectomized partner;
  • have had a hysterectomy;
  • a bilateral oophorectomy or be clinically diagnosed infertile;
  • or be in a menopausal state for at least a year.
  • Subject is judged to be in good general health as determined by the principal investigator.

Exclusion Criteria:

• unable to understand and provide written consent
• Have received prior intralesional steroids for AKN within the past 6 months
• Are using topical steroids or topical medications on their scalp within 4 weeks
• Have used Duobrii on the scalp for AKN or other scalp disorders
• Subject is pregnant or breastfeeding
• Use of prior systemic medication for AKN or acne (doxycycline or isotretinoin) or hair loss in the last 6 months
• Currently using topical minoxidil or prior use within the past 3 months
• Have a history of other or other active scalp/hair disease or other forms of or other forms of alopecia
• Are on systemic steroids or other immunosuppressants
• Have a history of auto-immune disease, thyroid disorder, or hypersensitivity to steroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Topical does not contain active properties of study drug
Experimental: Duobrii; Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.	Drug: Duobrii; topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks; Other Names: halobetasol propionate and tazarotene; Drug: Bryhali; Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Bryhali lotion once daily up to 12 weeks only if Duobrii is not tolerated.; Other Names: halobetasol propionate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lesion Count	Change in Lesion Count between baseline and Week 12	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain Rating Scale	Changes in Pain Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN pain symptoms.	Baseline and Week 12
Changes in Itch Rating Scale	Changes in Itch Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN itch symptoms.	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: Benjamin N Ungar, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Actual): April 15, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Hair Diseases; Acneiform Eruptions; Collagen Diseases; Keloid; Folliculitis; Skin and Connective Tissue Diseases; Acne Keloid; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Keratolytic Agents; Vasoconstrictor Agents; halobetasol; tazarotene
• Other Study ID Numbers: GCO-22-0955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available. Aggregated data will be discussed in the final published article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No