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Actively Recruiting

Researchers are studying moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI) to compare the effects of oral isotretinoin against the current standard treatment on acne-related pigmentation (ARP). ARP affects about 65% of these patients and impacts quality of life by causing discoloration. The study aims to see if isotretinoin, usually prescribed only after antibiotics fail, is better as a first-line treatment for ARP severity after six months. This is a Phase 3, multicenter, randomized controlled trial involving 420 subjects. Participants will receive either oral isotretinoin starting at 0.5 mg/kg daily (adjusted based on tolerance and response, with a total cumulative dose target of 120 to 150 mg/kg) or a topical cream (retinoic acid or adapalene) combined with oral antibiotics (doxycycline or lymecycline) for the first three months. After three months, the effectiveness will be checked; if acne improves, antibiotics stop but topical treatment continues. If acne remains moderate or severe, isotretinoin may be started. The study compares these approaches over six months. During the study, participants will be monitored for acne severity and pigmentation changes. They must have a cell phone capable of taking high-quality selfie pictures for monitoring. Safety tests include blood work for liver function and lipids. Women of childbearing potential will have pregnancy tests and require effective contraception. Researchers will assess the severity of acne-related pigmentation at six months as the primary outcome. The study will last six months with close follow-up and clinical evaluations to track treatment response and safety.

Age: 13Years - 30YearsAll GendersPhase 3
16 locations
F

Actively Recruiting

Researchers are conducting a French prospective observational study to understand how patients aged 18 years and older with moderate to severe atopic dermatitis (AD) are managed when eligible for or currently receiving systemic therapy. The study aims to describe treatment patterns, including previous and current therapies, and monitor drug survival and compliance over time. Experienced dermatologists in hospital and office settings will participate, ensuring treatment decisions reflect real-world clinical practice. Patients will be followed for one year under routine care, with systemic treatment decisions made solely by their physicians independent of study enrollment. The study does not involve specific interventions or changes in treatment but observes the use and management of systemic therapies for AD, including topical corticosteroid use and other systemic options. Participants will complete questionnaires and undergo assessments at baseline, six months, and twelve months. Researchers will collect data on previous and current treatments, therapeutic management of atopic comorbidities, drug survival changes, and treatment adherence. The study focuses on gathering real-life information on systemic therapy use and patient outcomes over the 12-month follow-up period.

Age: 18Years +All Genders
60 locations
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