Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

NCT05608499 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: GCO-22-0955
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Keloidalis Nuchae; AKN

Outcome Measures

Primary Outcomes (1)

• Change in Lesion Count

  Change in Lesion Count between baseline and Week 12

  Baseline and Week 12

Secondary Outcomes (2)

• Changes in Pain Rating Scale

  Baseline and Week 12

• Changes in Itch Rating Scale

  Baseline and Week 12

Study Arms (2)

Duobrii

EXPERIMENTAL

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

Drug: Duobrii; Drug: Bryhali

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Duobrii DRUG

topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks

Also known as: halobetasol propionate and tazarotene

Duobrii

Placebo DRUG

Topical does not contain active properties of study drug

Placebo

Bryhali DRUG

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.

Also known as: halobetasol propionate

Duobrii

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Acne Keloid

Interventions

halobetasol; tazarotene

Condition Hierarchy (Ancestors)

Keloid; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Skin Diseases; Folliculitis; Hair Diseases

Results Point of Contact

• Title: Giselle Singer
• Organization: Icahn School of Medicine at Mount Sinai

giselle.singer@mssm.edu

212-241-3288

Study Officials

• Benjamin N Ungar

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 26, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: November 4, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)