Duobrii Treatment 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.
Conditions:
🦠 Acne Keloidalis Nuchae 🦠 AKN
🗓️ Study Start (Actual) 26 October 2022
🗓️ Primary Completion (Estimated) October 2024
✅ Study Completion (Estimated) October 2024
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 November 2022
  • First Submitted that Met QC Criteria 1 November 2022
  • First Posted 8 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 October 2023
  • Last Update Posted 10 October 2023
  • Last Verified October 2023