Acne Vulgaris
Conditions
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
Interventions
DRUGISOtretinoin 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.
DRUGTopical 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.
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 30 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of score acne-related pigmentation | at 6 months | To assess the superiority after 6 months of a first line oral isotretinoin treatment of moderate facial acne in skin of color patients compared to the current standard of care on the severity of ARP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life of patient | at 6 months | Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL) |
| Number of adverse events | during 6 months | A special focus on scars will be performed using an Investigator Global Assessment score (0 no scar, 1 mild scarring, 2 moderate, 3 severe) over the study period. |
Countries
France, French Guiana
Contacts
CONTACTThierry Passeron, PhD
CONTACTEmmanuelle Pradelli
PRINCIPAL_INVESTIGATORThierry Passeron, PhD
CHU de Nice, Service de Dermatologie
Outcome results
None listed