drugset / Trial / NCT03064438

Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea

NCT03064438 ↗

Phase 2 Completed 40 enrolled Accuitis, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.

Timeline

Start
2017-11-28
Primary completion
2018-06-05
Completion
2018-06-18

Outcome

Missed primary endpoint

registry analysis (superiority test); ACU-D1 Ointment vs ACU-D1 Ointment Vehicle; p = 0.366; Difference of Least Squares (LS) Mean 1.8 (95% CI -2.162 to 5.727) NCT03064438 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ACCU-D1 Unknown — Topical

Indications