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Cream combo tested for scalp bumps in men of african descent

NCT ID NCT05608499

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

15 people

The number who actually took part.

Started

Oct 2022

Finished

Apr 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States