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Completed

NCT Number: NCT05245578

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

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Key information

Conditions

Healthy Volunteer Dermatitis Dermatitis, Contact Dermatitis, Irritant Dermatitis, Phototoxic Photosensitivity Disorders Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Toshima-ku, Tokyo, 171-0014, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of photosensitivity or photoallergy

Treatment and study plan

KX01 ointment 1%

Drug

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.

Placebo Ointment

Drug

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.

Primary outcomes

  1. Degree of skin irritation at application site

    Time frame: 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.

  2. Phototoxic potential at application site

    Time frame: 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 outcomes

  1. Number of participants with adverse events as a measure of safety

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

PharmaEssentia

Industry

Collaborators

  • PharmaEssentia Japan K.K.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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