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A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

NCT05231044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-04-19

No results posted yet for this study

Summary

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

Conditions

  • Actinic Keratosis

Interventions

DRUG

KX01 ointment 1%

The experimental drug, KX01 Ointment 1% is used in participants with Clinically typical AK on the face or scalp.

DRUG

Placebo

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

Sponsors & Collaborators

  • PharmaEssentia Japan K.K.

    collaborator INDUSTRY

  • PharmaEssentia

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2023-11-20
Completion
2023-11-20

Countries

  • Japan

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 NCT05231044 on ClinicalTrials.gov