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NCT05608499 · ClinicalTrials.gov registry record · Phase 3
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
A Phase 3 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Terminated
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
NCT05608499 is a Phase 3 study that was terminated before completion, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 15 participants.
The verdict
NCT05608499, a Phase 3 study, was terminated before completion, sponsored by Icahn School of Medicine at Mount Sinai.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Duobrii
- DRUG Bryhali
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05608499
The ClinicalTrials.gov registry entry for NCT05608499 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05608499 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05608499 about?
NCT05608499 is a clinical study titled "Duobrii Treatment of Acne Keloidalis Nuchae (AKN)". 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 i...
What is the current status of trial NCT05608499?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2022-10-26. Estimated completion is 2024-04-15.
What interventions are being tested in trial NCT05608499?
The interventions under investigation include: Placebo (DRUG), Duobrii (DRUG), Bryhali (DRUG).
Who is sponsoring clinical trial NCT05608499?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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