Cream combo tested for scalp bumps in men of african descent
NCT ID NCT05608499
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested Duobrii, a prescription cream that combines a strong steroid with a retinoid, for treating early-mild acne keloidalis nuchae (AKN) — a chronic scalp condition causing bumps and scarring, mainly in men of African descent. The trial planned to enroll 15 adults with mild AKN and track changes in lesion counts over 12 weeks. However, the study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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15 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States