NCT05231044

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

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a double-blinded, multicenter, activity, and safety study of KX01 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations is performed.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2022-02-09
• Last updated: 2024-04-19

Locations

20 sites across 1 country: Japan