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A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp

NCT03285477 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2021-04-13

Study results available
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Summary

This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment 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 Keratoses

Interventions

DRUG

Placebo

Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.

DRUG

KX2-391 Ointment 1%

The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.

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
2017-09-18
Primary Completion
2018-05-03
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 NCT03285477 on ClinicalTrials.gov