NCT02838628

Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.

Detailed description

This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK. The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	50 mg of KX2-391 Ointment 1%	Dose: 50 mg; Route of administration: Topical
DRUG	50 mg of KX2-391 Ointment 1%	Dose: 50 mg; Route of administration: Topical

Timeline

• Start date: 2016-04-11
• Primary completion: 2017-01-11
• Completion: 2017-12-22
• First posted: 2016-07-20
• Last updated: 2021-04-14
• Results posted: 2021-04-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study