Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Inclusion Criteria:

• Male or female subject at least 18 years of age

• Subject is able to provide written informed consent and comply with the requirementsof 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 urinepregnancy test at screening and must be practicing an adequate and medicallyacceptable 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 atleast 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 principalinvestigator.

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) orhair 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 orother forms of alopecia

• Are on systemic steroids or other immunosuppressants

• Have a history of auto-immune disease, thyroid disorder, or hypersensitivity tosteroids.