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Actively Recruiting

Phase 3
Age: 13Years - 30Years
All Genders
ID06447480

Study Comparing Oral Isotretinoin to Standard Treatment for Moderate Acne in People with Darker Skin Types

Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-20

420

Participants Needed

19

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for moderate acne in patients with darker skin types Fitzpatrick phototypes IV-VI, focusing on acne-related pigmentation that affects quality of life. This randomized controlled trial compares oral isotretinoin as a first-line treatment against the current standard of care involving oral antibiotics and topical creams. The study aims to assess which approach better improves pigmentation severity after six months. Participants will be assigned to one of two groups. One group receives oral isotretinoin starting at 0.5 mgkg daily for six months, with dose adjustments possible based on tolerance and effectiveness. The other group follows standard care, receiving topical tretinoin or adapalene along with doxycycline or lymecycline for three months, followed by evaluation at three and six months. Dose changes may occur according to clinical response. During the study, participants will attend monthly visits if receiving isotretinoin or visits at three and six months for the standard care group. Researchers will assess acne-related pigmentation severity, quality of life, and any adverse events. Participants must have a cell phone capable of taking high-definition selfies to assist in monitoring. The total study duration for each participant is six months, with ongoing safety and effectiveness checks.

CONDITIONS

Brief 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, or VI (darker skin tones)
  • Moderate acne according to French Society of Dermatology recommendations based on ECLA grading
  • Ability to use a cell phone with a camera of at least 5 Megapixels for selfies
  • Signed informed consent
  • Affiliated with French social coverage
Not Eligible

You will not qualify if you...

  • Mild or severe acne according to ECLA grading
  • Previous treatment with oral isotretinoin
  • 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 to use effective contraception for women of childbearing potential
  • Contraindications to isotretinoin, doxycycline, lymecycline, or topical adapalene/tretinoin
  • Vulnerable individuals under guardianship or deprived of liberty

Research Team

T

Thierry Passeron, PhD

E

Emmanuelle Pradelli

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