Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447480
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients ETHNIC Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETHNIC
Brief Summary:
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 eg topicals in mild acne and isotretinoin in severe acne In darker skin type patients ie 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 ie 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 guidelinesThe 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 ARPMulticenter randomized controlled trial - open study The number of subjects required for the trial 420
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None