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

NCT05245578 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-02-18

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteer

Interventions

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.

Sponsors & Collaborators

  • PharmaEssentia Japan K.K.

    collaborator INDUSTRY

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Hisakuni Sekino · Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2021-11-22
Completion
2022-01-12

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05245578 on ClinicalTrials.gov