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

February 16, 2022 updated by: PharmaEssentia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Toshima-ku, Tokyo, Japan, 171-0014
        • Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • History of photosensitivity or photoallergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KX01 ointment and Placebo ointment
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 days
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.
9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events as a measure of safety
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PharmaEssentia

Collaborators

PharmaEssentia Japan K.K.

Investigators

  • Principal Investigator: Hisakuni Sekino, Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2021

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 18, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B21-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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