MedTrace Logo

A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)

NCT03285490 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2021-03-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Actinic Keratosis

Interventions

DRUG

KX2-391 Ointment 1%

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

DRUG

Placebo

Dosage form: Ointment; Route of administration: Topical

Sponsors & Collaborators

  • Athenex, Inc.

    collaborator INDUSTRY

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Jane Fang, MD · Athenex, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2018-05-07
Completion
2019-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03285490 on ClinicalTrials.gov