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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245578
• Other study ID #: B21-101
• Status: Completed
• Phase: Phase 1
• Start date: November 16, 2021
• Est. completion date: January 12, 2022

Study information

• Verified date: February 2022
• Source: PharmaEssentia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 12, 2022
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• History of photosensitivity or photoallergy

Related Conditions & MeSH terms

• Dermatitis, Phototoxic
• Healthy Volunteer

Intervention

Drug:
• KX01 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.
• Placebo ointment
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.

Locations

Country	Name	City	State
Japan	Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic	Toshima-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
PharmaEssentia	PharmaEssentia Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of skin irritation at application site	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.	9 days
Primary	Phototoxic potential at application site	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.	9 days
Secondary	Number of participants with adverse events as a measure of safety		9 days