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

Study acronym: PANDORA
StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoint added 2 → 3 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Recruitment opened
    • Start date: Mar 2026 to Aug 24, 2026
    • Enrollment target: 526 to 531
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  2. Secondary endpoints: details revised at 1 of 3 entries
    • Study title shortened, about 6 words
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06905210
Lead Sponsor Eurofarma Laboratorios S.A.
Conditions
(from sponsor)		 Acne Vulgaris, Acne Vulgaris on the Face
Related terms Acne Vulgaris
Enrollment 531 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov