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KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis

NCT05522816 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-07-02

No results posted yet for this study

Summary

This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 in the treatment of patients with plaque-type psoriasis.

Conditions

Interventions

DRUG

KX01 0.01% (0.1 mg/g)

Stage 1: 6 patients (KX01 0.01% \[0.1 mg/g\])

DRUG

Placebo

Contains same excipients with KX01 but do not contain Tirbanibulin

DRUG

KX01 0.1% (1.0 mg/g)

Stage 2: 6 patients (KX01 0.1% \[1.0 mg/g\])

DRUG

KX01 1% (10 mg/g) for 5 days

Stage 3: 6 patients (KX01 1% \[10 mg/g\]) for 5 days

DRUG

KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles

Stage 4: 6 patients (KX01 1% \[10 mg/g\])for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Principal Investigators

  • Jin-Bon Hong, M.D. · Department of Dermatology, National Taiwan University Hospital, Taipei, Taiwan

  • Po-Yuan Wu, M.D., Ph.D. · Department of Dermatology, China Medical University Hospital, Taichung, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-27
Primary Completion
2021-03-10
Completion
2021-03-10

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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 NCT05522816 on ClinicalTrials.gov