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Skincare breakthrough? new study tests niacinamide creams for dark spots in black women

NCT ID NCT07618572

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 is testing whether a daily skincare routine with niacinamide and bioceramides can reduce facial dark spots (post-inflammatory hyperpigmentation) and improve self-esteem and quality of life in 60 Black women with darker skin tones. Participants will use a cleanser, moisturizer, serum, and sunscreen for 12 weeks, and doctors will track changes in pigmentation and well-being through photos and questionnaires.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Niacinamide and Bioceramide-Based Skincare Regimen
What this could lead to
If it works, this could offer a simple, non-prescription skincare routine to reduce facial dark spots and boost self-esteem in Black women.
What could go wrong
This is a small, early-stage study with only 60 participants and no comparison group, so results may not apply broadly. The improvement may be modest or temporary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

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 to 55 years

Sex

Female participants only

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: * Female participants aged 18 to 55 years * Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH) * Self-identified as Black (including "preta" or "parda") * Fitzpatrick skin types IV to VI * Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units * Willing and able to comply with all study procedures and attend all scheduled visits * Able and willing to provide written informed consent and authorization for image use Exclusion Criteria: * Pregnant or breastfeeding women, or those planning pregnancy during the study period * Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma) * Known or suspected intolerance to similar cosmetic products * History of atopy or allergic reactions to cosmetic products * Personal or family history of skin cancer * Active skin conditions or lesions affecting the face * Facial marks or scars that may interfere with assessments * Skin irritation due to recent sun exposure * Excessive sun or UV exposure, including artificial tanning, within the past month * Use of facial cosmetic products within 7 days before screening * Use of topical or systemic treatments within 1 month before screening * Use of depigmentation treatments within 3 months before screening * Use of dermocosmetic treatments for PIH within 3 months before screening * Facial dermatological or aesthetic procedures within 2 weeks before screening * Use of corticosteroids, anticoagulants, or immunosuppressive drugs * Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7) * Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Israelita Albert Einstein

    RECRUITING

    São Paulo, São Paulo, 05652-900, Brazil

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