Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

Acne Vulgaris Clinical Trial

— ETHNIC  

Official title:

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06447480
• Other study ID #: 22-APN-02
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Thierry Passeron, PhD
• Phone: +33492036488
• Email: passeron.t[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

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-pos t-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-po st-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 ß-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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• ISOtretinoin 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.
• Topical 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.

Locations

Country	Name	City	State
France	CH D'argenteuil	Argenteuil
France	CHU de Bordeaux	Bordeaux	Aquitaine
France	Cabinet Dermatologique Brest 1	Brest
France	Cabinet Dermatologique Brest 2	Brest
France	Cabinet dermatologique Cenon	Cenon
France	Cabinet dermatologique gradignan	Gradignan
France	CHU de la réunion	La Réunion
France	CHU de Nantes	Nantes	Loire-Atlantique
France	CHU de Nice - Hôpital de l'Archet	Nice	Alpes-Maritimes
France	APHP	Paris	Ile De France
France	Cabinet dermatologique privé	Paris
France	CH Avicenne - APHP	Paris
France	Hôpital Béclére	Paris
France	chu de Rouen	Rouen	Seine-maritime
France	Cabinet de dermatologie St Maxime	Sainte-Maxime	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of score acne-related pigmentation	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.	at 6 months
Secondary	Quality of life of patient	Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)	at 6 months
Secondary	Number of adverse events	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.	during 6 months