Study of New Antiandrogenic Progestogen + Low-dose Estrogen for Moderate Acne Vulgaris

This Phase III randomized, double-blind, placebo-controlled, adaptive, multicenter study evaluates the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris over six 28-day treatment cycles. Eligible participants will be randomized (2:1) to receive either the experimental drug or placebo alongside standard skincare. The study includes five in-person visits (screening, randomization, and three follow-ups) and three phone contacts (cycles 2, 4, and 5) to monitor adherence, adverse events, and contraceptive use. A subgroup will undergo additional exploratory assessments, including acne questionnaires, ovarian activity tests, photographic documentation, and specialized lab/ultrasound exams.

NCT Number	NCT06905210
Lead Sponsor	Eurofarma Laboratorios S.A.
Conditions	Acne Vulgaris, Acne Vulgaris on the Face
Enrollment	526 participants
Start Date	2026-03
Primary Completion	2027-02 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-04-04