Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Acne Keloidalis Nuchae Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608499
• Other study ID #: GCO-22-0955
• Status: Recruiting
• Phase: Phase 3
• Start date: October 26, 2022
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Giselle Singer
• Phone: 212-241-3288
• Email: giselle.singer[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Keloid
• Acne Keloidalis Nuchae
• AKN

Intervention

Drug:
• Duobrii
topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks
• Placebo
Topical does not contain active properties of study drug
• Bryhali
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in degree of dyspigmentation	Changes in percent of treatment area affected with dyspigmentation as compared to baseline.	Baseline and Week 12