Acne VulgarisPhase 3ETHNICNCT06447480
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
A Phase 3 study testing ISOtretinoin 5 MG and Topical cream in people with Acne Vulgaris, run by Centre Hospitalier Universitaire de Nice at 19 sites in 2 countries.
Trial summary
In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- ISOtretinoin 5 MG and Topical cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 29 Apr 2025to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 2 countries
France17 sites, 17 recruiting
- Recruiting
CH D'argenteuil
Argenteuil
Emmanuel MAHE, Ph, emmanuel.mahe@ch-argenteuil.fr
emmanuel Mahé, Ph
- Recruiting
CHU de Bordeaux
Bordeaux, Aquitaine, 33000
Marie Beylot-Barry, PhD, marie.beylot-barry@chu-bordeaux.fr
Marie Beylot-Barry, PhD
- Recruiting
Cabinet Dermatologique Brest 1
Brest
Nicolas Jouan, Ph, nicole.jouan@wanadoo.fr
Nicole Jouan, Ph
- Recruiting
Cabinet Dermatologique Brest 2
Brest
Martine Schollhammer, Ph, Martine.schollhammer@wanadoo.fr
Martine Schollhammer, Ph
- Not yet recruiting
Cabinet dermatologique Cenon
Cenon
Jean-Michel Amici, Ph, jmamici@gmail.com
Jean-Michel Amici, Ph
- Recruiting
Cabinet dermatologique gradignan
Gradignan
Sandra Ly, Ph, dr.sandra.ly67@gmail.com
Sandra Ly, Ph
- Recruiting
CHU de la réunion
La Réunion
Antoine Bertolotti, PhD, antoine_bertolotti@yahoo.fr
antoine bertolotti, PhD
- Recruiting
CHU de Nantes
Nantes, Loire-Atlantique, 44 000
Marie Lemoigne, Ph, marie.lemoigne@chu-nantes.fr
Marie Lemoigne, Ph
- Recruiting
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, 06200
Thierry Passeron, PhD, +33492036488, passeron.t@chu-nice.fr
Thierry Passeron, PhD
- Recruiting
Ambroise paré
Paris
Tu-Anh Duong, Ph, tu-anh.duong@aphp.fr
Tu-Anh Duong, Ph
- Not yet recruiting
Cabinet dermatologique privé
Paris
Pierre Schneider, Ph, drpierreschneider@gmail.com
Pierre Schneider, Ph
- Recruiting
Cabinet dermatologique
Paris
Christelle Comte, 06.50.72.89.09, Dr.ch.comte@gmail.com
Christelle Comte
- Recruiting
CH Avicenne - APHP
Paris
Gérome Bohelay, Ph, gerome.bohelay@gmail.com
Gérôme Bohelay, Ph
- Recruiting
APHP
Paris, Île-de-France Region, 75000
Coralie Lheure, PhD, coralie.lheure@aphp.fr
Coralie LHEURE, PhD
- Recruiting
CHU de Poitiers
Poitiers
Da Hee Pitaud, Ph, 0549444459, Da-hee.pitaud@chu-poitiers.fr
Da Hee Pitaud
- Recruiting
chu de Rouen
Rouen, Seine-maritime, 76000
Pascal Joly, PhD, pascal.joly@chu-rouen.fr
pascal joly, PhD
- Recruiting
Cabinet de dermatologie St Maxime
Sainte-Maxime, Var, 83000
Marc Reverte, Ph, dr.reverte@orange.fr
Marc Reverte, Ph
French Guiana2 sites, 2 recruiting
- Recruiting
CH de Cayenne 3 Avenue Alexis Blaise, BP6006
Cayenne, 97306
Romain BLAIZOT, 0594397799, romain.blaizot@ch-cayenne.fr
william faurous, 0594397799, william.faurous <william.faurous@ch-cayenne.fr>
- Recruiting
Cabinet de dermatologie DERMACLINIC 972
Fort-de France
emilie baubion, Ph, 0767292250, dr.emilie.baubion@gmail.com
Emilie Baubion
About this study
Official title: Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420
- Conditions
- Acne Vulgaris
- Being tested
- ISOtretinoin 5 MG, Topical cream
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOtretinoin 5 MGDrug
The dose is usually of 0.5 mg/kg/d. If tolerance is poor, the dose of isotretinoin can be decreased to 0.25 mg/kg/d.
After 3 months of treatment, a clinical evaluation is performed. The dose of isotretinoin can be increased up to 1 mg/kg/d depending on the efficacy (ECLA graded as moderated or severe) and tolerance. A total cumulative dose between 120 to 150 mg/kg is recommended.
Topical creamDrug
Topical retinoic acid (Effederm®) or adapalene cream (Differine®), associated during the 3 first months with doxycycline or lymecycline 100 mg/d. After 3 months, the efficacy is assessed. If acne improved, oral antibiotics are stopped and only the topical treatment is continued. If the ECLA is graded as moderated or severe, isotretinoin should be introduced.
| Study group | Role | What they receive |
|---|---|---|
| Drug group | Experimental | Patients will be followed every month for 6 months in the group isotretinoin. Patients will start at the dose of 0.5 mg/kg/d. If tolerance is poor, the dose could be decrease to 0.25mg/d. After 3 months, following the recommendations the dose could be increase up to 1mg/kg/d depending on the efficacy. Receives: Drug: ISOtretinoin 5 MG |
| Doxycycline | Active comparator | Patients will be followed at 3 and 6 months in the group "standard of care". They will be prescribed topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d. Receives: Drug: Topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of score acne-related pigmentation
To assess the superiority after 6 months of a first line oral isotretinoin treatment of moderate facial acne in skin of color patients compared to the current standard of care on the severity of ARP.
Measured: at 6 months
Secondary outcomes (2)
Quality of life of patient
Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)
Measured: at 6 months
Number of adverse events
A special focus on scars will be performed using an Investigator Global Assessment score (0 no scar, 1 mild scarring, 2 moderate, 3 severe) over the study period.
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start29 Apr 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447480
- Sponsor's protocol ID
- 22-APN-02
- Acronym
- ETHNIC
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
- ClinicalTrials.gov ID
- NCT06447480
- Acronym / sponsor ID
- ETHNIC / 22-APN-02
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug group | Experimental | Drug: ISOtretinoin 5 MGPatients will be followed every month for 6 months in the group isotretinoin. Patients will start at the dose of 0.5 mg/kg/d. If tolerance is poor, the dose could be decrease to 0.25mg/d. After 3 months, following the recommendations the dose could be increase up to 1mg/kg/d depending on the efficacy. |
| Doxycycline | Active comparator | Drug: Topical creamPatients will be followed at 3 and 6 months in the group "standard of care". They will be prescribed topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISOtretinoin 5 MGThe dose is usually of 0.5 mg/kg/d. If tolerance is poor, the dose of isotretinoin can be decreased to 0.25 mg/kg/d. After 3 months of treatment, a clinical evaluation is performed. The dose of isotretinoin can be increased up to 1 mg/kg/d depending on the efficacy (ECLA graded as moderated or severe) and tolerance. A total cumulative dose between 120 to 150 mg/kg is recommended. | Drug | Drug group |
| Topical creamTopical retinoic acid (Effederm®) or adapalene cream (Differine®), associated during the 3 first months with doxycycline or lymecycline 100 mg/d. After 3 months, the efficacy is assessed. If acne improved, oral antibiotics are stopped and only the topical treatment is continued. If the ECLA is graded as moderated or severe, isotretinoin should be introduced. | Drug | Doxycycline |
Primary outcome
Severity of score acne-related pigmentation
Time frame: at 6 months
To assess the superiority after 6 months of a first line oral isotretinoin treatment of moderate facial acne in skin of color patients compared to the current standard of care on the severity of ARP.
2 secondary outcomes
Quality of life of patient
Time frame: at 6 months
Number of adverse events
Time frame: during 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thierry Passeron, PhD principal investigator
CHU de Nice, Service de Dermatologie
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ISOtretinoin 5 MG and Topical cream in people with Acne Vulgaris, run by Centre Hospitalier Universitaire de Nice at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry Passeron, PhD (+33492036488, passeron.t@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of score acne-related pigmentation (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.