Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
Acne Keloidalis Nuchae, AKN
About this trial
This is an interventional treatment trial for Acne Keloidalis Nuchae
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.
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Duobrii
Placebo
Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.
Placebo