NCT06447480 Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
| NCT ID | NCT06447480 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Acne Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2025-04-29 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Thierry Passeron, PhD
PRINCIPAL INVESTIGATOR
CHU de Nice, Service de Dermatologie
Frequently Asked Questions
Who can join the NCT06447480 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 30 Years, studying Acne Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06447480 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT06447480 currently recruiting?
Yes, NCT06447480 is actively recruiting participants. Contact the research team at passeron.t@chu-nice.fr for enrollment information.
Where is the NCT06447480 trial being conducted?
This trial is being conducted at Nice, France, Bordeaux, France, Nantes, France, Rouen, France and 11 additional locations.
Who is sponsoring the NCT06447480 clinical trial?
NCT06447480 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Thierry Passeron, PhD at CHU de Nice, Service de Dermatologie. The trial plans to enroll 420 participants.