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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-09-01

Brief Summary

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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

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug group

Patients will be followed every month for 6 months in the group isotretinoin. Patients will start at the dose of 0.5 mg/kg/d. If tolerance is poor, the dose could be decrease to 0.25mg/d. After 3 months, following the recommendations the dose could be increase up to 1mg/kg/d depending on the efficacy.

Group Type EXPERIMENTAL

ISOtretinoin 5 MG

Intervention Type DRUG

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.

Doxycycline

Patients will be followed at 3 and 6 months in the group "standard of care". They will be prescribed topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d.

Group Type ACTIVE_COMPARATOR

Topical cream

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Passeron, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Nice, Service de Dermatologie

Locations

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CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, France

Site Status RECRUITING

CHU de Bordeaux

Bordeaux, Aquitaine, France

Site Status RECRUITING

CHU de Nantes

Nantes, Loire-Atlantique, France

Site Status RECRUITING