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Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis

Actinic Keratoses Clinical Trial

Official title:
A Phase 1 Open-label, Uncontrolled, Non-randomized, Maximal Use Pharmacokinetic Study to Evaluate the Systemic Exposure and Safety of KX2-391 Ointment 1% When Applied to 25 cm2 of the Face or Balding Scalp in Subjects With Actinic Keratosis

Clinical Trial Summary

This Phase I study is designed to evaluate the systemic exposure and safety of KX2-391 Ointment in adult subjects when applied to an area of skin containing at least 5 clinically typical, visible, and discrete Actinic Keratosis lesions on the face or balding scalp.

Clinical Trial Description

This study will be a open-label, single center, pharmacokinetic, and safety study of KX2-391 Ointment administered topically to the face or balding scalp of subjects with actinic keratosis.

The study consists of Screening, Treatment, and Follow-up Periods. Eligible subjects will receive 5 consecutive days of topical treatment, to be applied at the same location. Activity (lesion counts) and safety evaluations will be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03575780
Study type Interventional
Source Athenex, Inc.
Contact
Status Completed
Phase Phase 1
Start date September 7, 2018
Completion date October 10, 2019
View Details
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