Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Study Overview
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Brief Summary
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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.

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

Conditions
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Acne Keloidalis Nuchae, AKN

Intervention / Treatment
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* Drug: Duobrii
* Drug: Placebo
* Drug: Bryhali


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lesion count classification | Changes in lesion count classification as captured by photography. AKN Classification: Lesion Distribution Class I: sagittal width ≤ 3cm Class II: sagittal width < 3cm ≤ 6.5cm | 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 | 
| Changes in degree of dyspigmentation | Changes in percent of treatment area affected with dyspigmentation as compared to baseline. | Baseline and Week 12 |