Back to results

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

Primary Purpose

Healthy Volunteer

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

KX01 ointment 1%

Placebo ointment

About this trial

This is an interventional treatment trial for Healthy Volunteer focused on measuring Skin Irritation, Phototoxicity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

History of photosensitivity or photoallergy

Sites / Locations

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KX01 ointment and Placebo ointment

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Number of participants with adverse events as a measure of safety

Full Information

NCT ID

NCT05245578

First Posted

December 30, 2021

Last Updated

February 16, 2022

Sponsor

PharmaEssentia

Collaborators

PharmaEssentia Japan K.K.

1. Study Identification

Unique Protocol Identification Number

NCT05245578

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

November 16, 2021 (Actual)

Primary Completion Date

November 22, 2021 (Actual)

Study Completion Date

January 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmaEssentia

Collaborators

PharmaEssentia Japan K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteer

Keywords

Skin Irritation, Phototoxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

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

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KX01 ointment and Placebo ointment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

KX01 ointment 1%

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo ointment

Intervention Description

Primary Outcome Measure Information:

Title

Degree of skin irritation at application site

Description

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.

Time Frame

9 days

Title

Phototoxic potential at application site

Description

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.

Time Frame

9 days

Secondary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety

Time Frame

9 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Japanese male adult, whose age 20-65 years old Exclusion Criteria: History of photosensitivity or photoallergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hisakuni Sekino

Organizational Affiliation

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

City

Toshima-ku

State/Province

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs