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

PHASE3RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

September 1, 2026

Study Completion Date

September 1, 2027

Conditions
Acne Vulgaris
Interventions
DRUG

ISOtretinoin 5 MG

"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."

DRUG

Topical cream

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.

Trial Locations (16)

33000

RECRUITING

CHU de Bordeaux, Bordeaux

75000

RECRUITING

APHP, Paris

76000

NOT_YET_RECRUITING

chu de Rouen, Rouen

83000

NOT_YET_RECRUITING

Cabinet de dermatologie St Maxime, Sainte-Maxime

97306

RECRUITING

CH de Cayenne 3 Avenue Alexis Blaise, BP6006, Cayenne

06200

RECRUITING

CHU de Nice - Hôpital de l'Archet, Nice

44 000

RECRUITING

CHU de Nantes, Nantes

Unknown

RECRUITING

CH D'argenteuil, Argenteuil

NOT_YET_RECRUITING

Cabinet Dermatologique Brest 1, Brest

NOT_YET_RECRUITING

Cabinet Dermatologique Brest 2, Brest

NOT_YET_RECRUITING

Cabinet dermatologique Cenon, Cenon

NOT_YET_RECRUITING

Cabinet dermatologique gradignan, Gradignan

RECRUITING

CHU de la réunion, La Réunion

NOT_YET_RECRUITING

Cabinet dermatologique privé, Paris

NOT_YET_RECRUITING

CH Avicenne - APHP, Paris

NOT_YET_RECRUITING

Hôpital Béclére, Paris

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER