BridgeMD
Compares treatment options for Acne Vulgaris
Official title Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
ClinicalTrials.gov ID: NCT06447480
What this study is testing
What is ISOtretinoin 5 MG?
ISOtretinoin 5 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acne vulgaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 30
You may be able to join if
- 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...
- Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb.
- Signed informed consent
You likely can't join if
- Mild and severe acne (ECLA grading : French recommendations)...
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nice, Alpes-Maritimes, France
- Bordeaux, Aquitaine, France
- Nantes, Loire-Atlantique, France
- Rouen, Seine-maritime, France
- Sainte-Maxime, Var, France
- Argenteuil, France
- Brest, France
- Cenon, France
- Gradignan, France
- La Réunion, France
- Paris, France
- Poitiers, France
- Paris, Île-de-France Region, France
- Cayenne, French Guiana
- Fort-de France, French Guiana
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nice, Alpes-Maritimes, France; Bordeaux, Aquitaine, France; Nantes, Loire-Atlantique, France; Rouen, Seine-maritime, France; Sainte-Maxime, Var, France; Argenteuil, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.