Isotretinoin for Acne

Inclusion criteria

• {"criterion_text":"- Women and men between 13 and 30-year-old"}
• {"criterion_text":"- Skin type IV, V and VI according to Fitzpatrick skin types"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb."}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- Affiliation to French social coverage"}

Exclusion criteria

• {"criterion_text":"- Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf)"}
• {"criterion_text":"- Vulnerable people: adult under guardianship or deprived of freedom"}
• {"criterion_text":"- Past cure of oral isotretinoin"}
• {"criterion_text":"- Past cure of systemic antibiotics for acne in the last 6 months"}
• {"criterion_text":"- Phototype I-III patients"}
• {"criterion_text":"- Abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline"}
• {"criterion_text":"- Pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hCG)"}
• {"criterion_text":"- Breast-feeding patients"}
• {"criterion_text":"- Refusal of effective contraception for women"}
• {"criterion_text":"- Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin"}

Primary endpoints

• {"endpoint_text":"- ARP severity score assessed by dedicated algorithm on facial pictures (selfies) at M6. This algorithm, developed to assess face skin aging hyperpigmented lesions is validated in ARP in dark skin types. The score ranges from 0 (no ARP) to 4 (severe ARP). A success is a patient with a score < 2 at M6 (ARP score<2 shows no or very mild ARP).","definition_or_measurement_approach":"Score assessed by a dedicated algorithm on facial selfies at month 6; algorithm validated in dark skin types; score 0–4; success defined as ARP score < 2 at M6."}

Secondary endpoints

• {"endpoint_text":"- Efficacity in subgroups will be evaluated as in main criteria at M6. The two subgroups will be patients with no or mild ARP at the inclusion (ARP score assessed by the algorithm on selfie <2) and the patients with already moderate to severe ARP (ARP score > or =2) at the inclusion.","definition_or_measurement_approach":"Subgroup efficacy evaluated at M6 using the ARP algorithm on selfies; subgroups defined by baseline ARP algorithm score <2 vs ≥2."}
• {"endpoint_text":"- The inflammatory and retentional lesions count will be assessed by dedicated algorithm on facial pictures (selfies) at 3 months and at 6 months. We will consider their evolution at M3 and M6 compared to baseline. Also, the evolution of inflammatory and retentional lesions will be assessed clinically by using the GEA scale grading.","definition_or_measurement_approach":"Lesion counts assessed by dedicated algorithm on selfies at M3 and M6 vs baseline; also clinically assessed using GEA scale grading."}
• {"endpoint_text":"- Number, grade and severity of adverse events in the two groups wil be presented. A special focus on scars will be performed using an IGA score (0 no scar, 1 mild scarring, 2 moderate, 3 severe) over the study period. For adolescent, ADRS (Adolescent Depression Rating Scale) will be additionally performed at each visit.","definition_or_measurement_approach":"AE number/grade/severity reported; scarring assessed by IGA score (0–3); adolescents assessed with ADRS at each visit."}
• {"endpoint_text":"- Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)","definition_or_measurement_approach":"Quality of life measured using the Acne-QoL questionnaire."}

France

Latest Decision Or Authorization Date

20-02-2026

Number Of Sites

20

Number Of Participants

420

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nice

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France