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

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05245578

Enrollment

Registered

2022-02-18

Start date

2021-11-16

Completion date

2022-01-12

Last updated

2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Skin Irritation, Phototoxicity

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.

Interventions

DRUGKX01 ointment 1%

A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.

DRUGPlacebo ointment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* History of photosensitivity or photoallergy

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame
Number of participants with adverse events as a measure of safety	9 days

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026