Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 19
- 主要终点
- Severity of score acne-related pigmentation
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Doxycycline
Patients will be followed at 3 and 6 months in the group "standard of care". They will be prescribed topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d.
干预措施: Topical cream (Drug)
Drug group
Patients will be followed every month for 6 months in the group isotretinoin. Patients will start at the dose of 0.5 mg/kg/d. If tolerance is poor, the dose could be decrease to 0.25mg/d. After 3 months, following the recommendations the dose could be increase up to 1mg/kg/d depending on the efficacy.
干预措施: ISOtretinoin 5 MG (Drug)
结局指标
主要结局
Severity of score acne-related pigmentation
时间窗: 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.
次要结局
- Quality of life of patient(at 6 months)
- Number of adverse events(during 6 months)