Clinical trial NCT05608499: Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
Official title: Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acne Keloidalis Nuchae
AKN
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2022-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in lesion count classification
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Changes in Pain Rating Scale
timeFrame: Baseline and Week 12
measure: Changes in Itch Rating Scale
timeFrame: Baseline and Week 12
measure: Changes in degree of dyspigmentation
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Benjamin N Ungar
role: PRINCIPAL_INVESTIGATOR
References: