Actively Recruiting
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-25
420
Participants Needed
16
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men between 13 and 30 years old
- Fitzpatrick skin types IV, V, and VI
- Moderate acne based on French Society of Dermatology ECLA grading
- Ability to use a cell phone that takes selfies with at least 5 Mb resolution
- Signed informed consent
- Affiliation to French social coverage
You will not qualify if you...
- Mild or severe acne according to French Society of Dermatology ECLA grading
- Previous oral isotretinoin treatment
- Use of systemic antibiotics for acne within the last 6 months
- Fitzpatrick skin types I to III
- Abnormal blood counts, liver enzymes, cholesterol, or triglycerides at baseline
- Pregnancy or breastfeeding
- Refusal of effective contraception for women of childbearing potential
- Contraindications to isotretinoin, doxycycline, lymecycline, or topical retinoids
- Vulnerable individuals such as those under guardianship or deprived of freedom
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, France, 06200
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, Aquitaine, France, 33000
Actively Recruiting
3
CHU de Nantes
Nantes, Loire-Atlantique, France, 44 000
Actively Recruiting
4
chu de Rouen
Rouen, Seine-maritime, France, 76000
Not Yet Recruiting
5
Cabinet de dermatologie St Maxime
Sainte-Maxime, Var, France, 83000
Not Yet Recruiting
6
CH D'argenteuil
Argenteuil, France
Actively Recruiting
7
Cabinet Dermatologique Brest 1
Brest, France
Not Yet Recruiting
8
Cabinet Dermatologique Brest 2
Brest, France
Not Yet Recruiting
9
Cabinet dermatologique Cenon
Cenon, France
Not Yet Recruiting
10
Cabinet dermatologique gradignan
Gradignan, France
Not Yet Recruiting
11
CHU de la réunion
La Réunion, France
Actively Recruiting
12
Cabinet dermatologique privé
Paris, France
Not Yet Recruiting
13
CH Avicenne - APHP
Paris, France
Not Yet Recruiting
14
Hôpital Béclére
Paris, France
Not Yet Recruiting
15
APHP
Paris, Île-de-France Region, France, 75000
Actively Recruiting
16
CH de Cayenne 3 Avenue Alexis Blaise, BP6006
Cayenne, French Guiana, 97306
Actively Recruiting
Research Team
T
Thierry Passeron, PhD
CONTACT
E
Emmanuelle Pradelli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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