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Randomized clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507519-36-00
Enrollment
420
Registered
2024-03-12
Start date
2025-04-29
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

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

DRUGLYMECYCLINE ARROW 408 mg (équivalent à 300 mg de tétracycline base)
DRUGgélule
DRUGDoxycycline EG 100 mg
DRUGcomprimés
DRUGEFFEDERM 0
DRUG05 %
DRUGcrème
DRUGADAPALENE ZENTIVA 0
DRUG1 %
DRUGDIFFERINE 0
DRUGPROCUTA 20 mg
DRUGPROCUTA 10 mg
DRUGPROCUTA 40 mg

Sponsors

Centre Hospitalier Universitaire De Nice
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026