Acne
Conditions
Brief summary
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).
Detailed description
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., 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., 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., Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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., 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., 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., Quality of life will be evaluated with the Acne-specific Qua | — |
Countries
France