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NCT06447480 | RECRUITING | Acne Vulgaris

Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Sponsor:

Nice University Hospital Center

Brief 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. 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

Condition or disease

Acne Vulgaris

Intervention/treatment

ISOtretinoin 5 MG

Topical cream

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 420 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2026-09-01
Estimated Study Completion Date : 2027-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 13 Years to 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

Location Details

NCT06447480

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

France, Alpes-Maritimes

Nice CHU - Archet Hospital

Nice, Alpes-Maritimes, France, 06200

RECRUITING

France, Aquitaine

Bordeaux CHU

Bordeaux, Aquitaine, France, 33000

RECRUITING

France, Ile de France

Gratu

Paris, Ile de France, France, 75000

RECRUITING

France, Loire-Atlantique

Nantes of Chu

Nantes, Loire-Atlantique, France, 44 000

NOT YET RECRUITING

France, Seine-maritime

Rouen

Rouen, Seine-maritime, France, 76000

NOT YET RECRUITING

France, Our

Dermatology firm St Maxime

Sainte-Maxime, Our, France, 83000

RECRUITING

France,

CH of Argenteuil

Argenteuil, France,

NOT YET RECRUITING

France,

Brest 1 dermatological office

Brest, France,

NOT YET RECRUITING

France,

Brest 2 dermatological cabinet

Brest, France,

NOT YET RECRUITING

France,

Cenon dermatological office

Cenon, France,

NOT YET RECRUITING

France,

Gradignan dermatological office

Gradignan, France,

RECRUITING

France,

Chu de la Réunion

Reunion, France,

NOT YET RECRUITING

France,

Private dermatological office

Paris, France,

NOT YET RECRUITING

France,

CH Avicenne - APHP

Paris, France,

NOT YET RECRUITING

France,

Béclere Hospital

Paris, France,

RECRUITING

French Guiana,

CH of Cayenne 3 avenue Alexis Blaise, BP6006

Cayenne, French Guiana, 97306