CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 351 enrolled
Drug / intervention
KX2-391 Ointment 1% +1 moredrug
Likely dose
KX2-391 Ointment 1% 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03285490
NCT03285490Phase 3Completed
CompareCT.gov

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp

Almirall, S.A.·interventional·Posted Sep 18, 2017·Updated Mar 10, 2021

In Brief

A Phase 3 clinical trial evaluating KX2-391 Ointment 1% and Placebo for Actinic Keratosis. Completed, enrolled 351 participants across 30 sites.

Detailed Summary

This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% in adult participants when applied to an area of skin containing 4-8 stable, clinically typical actinic keratosis (AK) lesions on the face or scalp.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
CollaboratorsAthenex, Inc.

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 18, 2017
Enrollment StartSep 15, 2017
Primary CompletionMay 7, 2018
Study CompletionApr 24, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.8 years ago

Interventions

KX2-391 Ointment 1%drug

Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical

Placebodrug

Dosage form: Ointment; Route of administration: Topical