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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug group | Experimental | 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. |
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| Doxycycline | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISOtretinoin 5 MG | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of patient | Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL) | at 6 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thierry Passeron, PhD | Contact | +33492036488 | passeron.t@chu-nice.fr | |
| Emmanuelle Pradelli | Contact | +33492036488 | pradelli.e@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thierry Passeron, PhD | CHU de Nice, Service de Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice - Hôpital de l'Archet | Recruiting | Nice | Alpes-Maritimes | 06200 | France |
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| Topical cream | 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. |
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| during 6 months |
| CHU de Bordeaux | Recruiting | Bordeaux | Aquitaine | 33000 | France |
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| CHU de Nantes | Recruiting | Nantes | Loire-Atlantique | 44 000 | France |
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| chu de Rouen | Recruiting | Rouen | Seine-maritime | 76000 | France |
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| Cabinet de dermatologie St Maxime | Recruiting | Sainte-Maxime | Var | 83000 | France |
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| CH D'argenteuil | Recruiting | Argenteuil | France |
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| Cabinet Dermatologique Brest 1 | Recruiting | Brest | France |
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| Cabinet Dermatologique Brest 2 | Recruiting | Brest | France |
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| Cabinet dermatologique Cenon | Not yet recruiting | Cenon | France |
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| Cabinet dermatologique gradignan | Recruiting | Gradignan | France |
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| CHU de la réunion | Recruiting | La Réunion | France |
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| Ambroise paré | Recruiting | Paris | France |
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| Cabinet dermatologique privé | Not yet recruiting | Paris | France |
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| Cabinet dermatologique | Recruiting | Paris | France |
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| CH Avicenne - APHP | Recruiting | Paris | France |
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| CHU de Poitiers | Recruiting | Poitiers | France |
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| APHP | Recruiting | Paris | Île-de-France Region | 75000 | France |
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| CH de Cayenne 3 Avenue Alexis Blaise, BP6006 | Recruiting | Cayenne | 97306 | French Guiana |
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| Cabinet de dermatologie DERMACLINIC 972 | Recruiting | Fort-de France | French Guiana |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| C585595 | Floderm topical cream |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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