Could a stronger acne drug be better for darker skin? new trial aims to find out

NCT ID NCT06447480

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares giving oral isotretinoin (a strong acne medication) right away versus the usual antibiotics for moderate acne in people with darker skin (Fitzpatrick types IV-VI). The goal is to see if early use of isotretinoin reduces acne-related dark spots better than standard care. About 420 participants aged 13-30 will be followed for 6 months.

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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

About 420 people

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

Started

Apr 2025

Expected to finish

Sep 2027

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

13 to 30 years

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: * Women and men between 13 and 30-year-old * Skin type IV, V and VI according to Fitzpatrick skin types * Moderate acne as defined by the French Society of Dermatology recommendations based on ECLA grading https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb. * Signed informed consent * Affiliation to French social coverage. Exclusion Criteria: * Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * Past cure of oral isotretinoin * Past cure of systemic antibiotics for acne in the last 6 months * Phototype I-III patients * Abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline * Pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hCG) * Breast-feeding patients * Refusal of effective contraception for women * Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin * Vulnerable people: adult under guardianship or deprived of freedom

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Conditions

The condition(s) this trial relates to.

acne Acne Vulgaris

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

    19 sites in 2 countries. 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

  • APHP

    RECRUITING

    Paris, Île-de-France Region, 75000, France

  • Ambroise paré

    RECRUITING

    Paris, France

  • CH Avicenne - APHP

    RECRUITING

    Paris, France

  • CH D'argenteuil

    RECRUITING

    Argenteuil, France

  • CH de Cayenne 3 Avenue Alexis Blaise, BP6006

    RECRUITING

    Cayenne, 97306, French Guiana

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, Aquitaine, 33000, France

  • CHU de Nantes

    RECRUITING

    Nantes, Loire-Atlantique, 44 000, France

  • CHU de Nice - Hôpital de l'Archet

    RECRUITING

    Nice, Alpes-Maritimes, 06200, France

  • CHU de Poitiers

    RECRUITING

    Poitiers, France

  • CHU de la réunion

    RECRUITING

    La Réunion, France

  • Cabinet Dermatologique Brest 1

    RECRUITING

    Brest, France

  • Cabinet Dermatologique Brest 2

    RECRUITING

    Brest, France

  • Cabinet de dermatologie DERMACLINIC 972

    RECRUITING

    Fort-de France, French Guiana

  • Cabinet de dermatologie St Maxime

    RECRUITING

    Sainte-Maxime, Var, 83000, France

  • Cabinet dermatologique

    RECRUITING

    Paris, France

  • Cabinet dermatologique Cenon

    NOT_YET_RECRUITING

    Cenon, France

  • Cabinet dermatologique gradignan

    RECRUITING

    Gradignan, France

  • Cabinet dermatologique privé

    NOT_YET_RECRUITING

    Paris, France

  • chu de Rouen

    RECRUITING

    Rouen, Seine-maritime, 76000, France

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