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

NCT05245578 | Completed Phase 1

• 1 other identifier: B21-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Skin Irritation; Phototoxicity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of participants with adverse events as a measure of safety

  9 days

Study Arms (1)

KX01 ointment and Placebo ointment

EXPERIMENTAL

Drug: KX01 ointment 1%; Drug: Placebo ointment

Interventions

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.

KX01 ointment and Placebo ointment

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.

KX01 ointment and Placebo ointment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of photosensitivity or photoallergy

Sponsors & Collaborators

• PharmaEssentia: lead
• PharmaEssentia Japan K.K.: collaborator

Study Sites (1)

Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

Toshima-ku, Tokyo, 171-0014, Japan

Location

MeSH Terms

Conditions

Dermatitis, Phototoxic

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Photosensitivity Disorders; Skin Diseases, Eczematous

Study Officials

• Hisakuni Sekino

  Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 18, 2022
• Study Start: November 16, 2021
• Primary Completion: November 22, 2021
• Study Completion: January 12, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

JP (1)