Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: KX01 ointment 1%; Drug: Placebo ointment

• Registration Number: NCT05245578
• Lead Sponsor: PharmaEssentia

Brief Summary

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects

Detailed Description

A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.

A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.

The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.

Study Timeline

• Study Start: 2021-11-16
• Primary Completion: 2021-11-22
• Study First Submitted: 2021-12-30
• Study Completion: 2022-01-12
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Healthy Japanese male adult, whose age 20-65 years old

Exclusion Criteria

• History of photosensitivity or photoallergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KX01 ointment and Placebo ointment	KX01 ointment 1%	-
KX01 ointment and Placebo ointment	Placebo ointment	-

Primary Outcome Measures

Name	Time	Method
Phototoxic potential at application site	9 days	Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.
Degree of skin irritation at application site	9 days	Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study.

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety	9 days

Trial Locations

Locations (1)

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic; 🇯🇵 Toshima-ku, Tokyo, Japan