Trials / Terminated
TerminatedNCT05608499
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. Enrolled participants will be instructed to apply placebo (n=10) vs. active (n=20) to affected area of the occipital scalp for 4 weeks once a day (label use). Each application will be approximately 1g. Following the 4 weeks, participants will be instructed to increase application to twice daily (BID; off-label; at least 8 hours apart) for one week. Investigators will conduct a phone visit on week 5 to discuss any potential side effects with this increased dose. If tolerated, this BID regimen will be carried throughout the length of the study. If BID is not tolerated (if irritation occurs), then Bryhali will be used as a "rescue treatment" once daily for 1 week before the subject returns to BID treatment with Duobrii. If irritation recurs, subjects will be instructed to alternate Duobrii and Bryhali (ie Duobrii BID one day, followed by Bryhali QD the next day, Duobrii BID the next, and so on). Alternating topical steroid use and stepping down topical steroid strength have been known to reduce lesion count in AKN.3 If irritation continues to persist, then participants will be instructed to use Bryhali QD for five days a week and Duobrii BID two days a week. If participants still experience irritation with this regimen, then subjects will be transitioned entirely to Bryhali QD for the remainder of the study. In case of clearance earlier than the end of the study, participants will be instructed to continue their respective regimen to completion of the study. Gentle hair care regimen will be recommended for duration of the length of the study; with unscented shampoo \& conditioner (such as Head \& shoulder) and Vaseline to scalp as moisturizer to minimize risk of contact dermatitis. In addition, patients will be instructed to postpone any form of hair coloring or chemical hair processing until after the study is over. Participants will be followed with visits scheduled at baseline, 4 weeks, 8 weeks and 12 weeks. At each visit, participants will complete surveys regarding the severity of AKN's associated symptoms (pain, pruritus, burning etc.) as well as the dermatology quality of life index (DLQI) and numerical rating scale (NRS) surveys (Appendix B\&D). In addition, photographs will also be obtained for global assessment and lesion count will be performed. The investigator will assess the treatment area for any dyspigmentation and document the % area affected within the treatment area at each visit. Tape strips will also be collected from lesional (occipital scalp) and non-lesional (frontal scalp) at Baseline and Week 12. There will be a phone call visit at week 5 to assess tolerance of medication increase and a safety follow-up visit at Week 14. Statistical analysis will be performed. Throughout the length of the study, any adverse events (AEs) related to the treatment will be recorded.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Duobrii | topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks |
| DRUG | Placebo | Topical does not contain active properties of study drug |
| 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. |
Timeline
- Start date
- 2022-10-26
- Primary completion
- 2024-04-15
- Completion
- 2024-04-15
- First posted
- 2022-11-08
- Last updated
- 2025-11-04
- Results posted
- 2025-10-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05608499. Inclusion in this directory is not an endorsement.