Actively Recruiting

Phase 3
Age: 13Years - 30Years
All Genders
NCT06447480

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

Age: 13Years - 30Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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