NCT06905210

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

Phase III Superiority, Randomized, Double-blind, Placebo-controlled, Adaptive, Multicenter Study to Compare the Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-dose Estrogen for the Treatment of Moderate Acne Vulgaris

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase III, randomized, double-blind, placebo-controlled, adaptive, multicenter superiority study to evaluate the efficacy and safety of a new concentration of the fixed-dose combination EF190 in women with moderate acne vulgaris after six treatment cycles. Eligible participants will be randomized into a controlled, double-blind treatment period, receiving either the experimental drug or placebo, along with standard skin care, for six 28-day cycles. Throughout the study, each participant must attend at least five (05) in-person clinic visits at the research center. At the screening visit (VS/V1), the participant will sign the Informed Consent Form (ICF) and the Assent Form (AF), undergo eligibility assessment, and have blood drawn. At the randomization visit (VR/V2), eligibility will be confirmed, baseline acne data (lesions and score) will be recorded, randomization (2:1 for treatment/placebo) will occur, and the study medication will be dispensed. The first dose (Day 1) will be administered on the 28th day post-menstruation. Subsequent visits (V3-V5/VF) will take place on day 15 (±3) of each cycle. The final visit (V5/VF) will assess the study's primary endpoint. In addition to in-person visits, participants will have three (3) phone contacts, scheduled between clinic visits during cycles 2, 4, and 5. These calls aim to reinforce treatment adherence, collect information on adverse events and concomitant medications, assess discontinuation criteria, and remind participants about the use of study-permitted contraceptive methods. Furthermore, a subgroup of participants will be selected for exploratory evaluations. These participants will complete acne control questionnaires, undergo ovarian activity assessments, have photographic documentation for acne evaluation, and receive specified laboratory and ultrasound tests as per the protocol and ICF/AF.

Conditions

• Acne Vulgaris
• Acne Vulgaris on the Face

Interventions

Type	Name	Description
DRUG	Placebo of the experimental drug	Subjects randomized to this group will receive one (01) placebo of the experimental drug everyday for 28 weeks.
DRUG	Experimental drug	Subjects randomized to this group will receive one (01) experimental drug everyday for 28 weeks.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-02-01
• Completion: 2027-03-01
• First posted: 2025-04-01
• Last updated: 2025-04-04

Locations

1 site across 1 country: Brazil