NCT03285490

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study was a double-blinded, multicenter, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK. The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-15
• Primary completion: 2018-05-07
• Completion: 2019-04-24
• First posted: 2017-09-18
• Last updated: 2021-03-10
• Results posted: 2021-03-10

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study